FDAClass IIFebruary 15, 2023

Sterile Procedural Trays recall

Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH…

Why was Sterile Procedural Trays recalled?

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a. EAR CDS-LF, Item Number: CDS982612B, Case UDI/GTIN: 40888277899729, Unit UDI/GTIN: 10888277899728, Lot Number: 22JBH351,22JBA043; b. SINUS CDS-1, Item Number: CDS982901F, Case UDI/GTIN: 40889942216971, Unit UDI/GTIN: 10889942216970, Lot Number: 22KBD129; c. ZALE FESS CDS, Item Number: CDS983178F, Case UDI/GTIN: 40195327164639, Unit UDI/GTIN: 10195327164638, Lot Number: 22JBC334,22IBC429; d. ZALE OTOLOGY CDS, Item Number: CDS983181F, Case UDI/GTIN: 40195327164646, Unit UDI/GTIN: 10195327164645, Lot Number: 22IBQ523,22IBJ058; e. ZALE HEAD & NECK CDS, Item Number: CDS983184I, Case UDI/GTIN: 40195327178353, Unit UDI/GTIN: 10195327178352, Lot Number: 22IBO795,22IBJ687; f. CUH PARA/THYROIDECTOMY CDS, Item Number: CDS983209J, Case UDI/GTIN: 40195327179794, Unit UDI/GTIN: 10195327179793, Lot Number: 22JBC280; g. CAM ENDOSCOPIC SINUS/SEPTO CDS, Item Number: CDS983499D, Case UDI/GTIN: 40193489749756, Unit UDI/GTIN: 10193489749755, Lot Number: 22IBU380,22HBW179; h. HEAD AND NECK CDS, Item Number: CDS983910K, Case UDI/GTIN: 40195327256594, Unit UDI/GTIN: 10195327256593, Lot Number: 22JBT244; i. HEAD AND NECK CDS-LF, Item Number: CDS984857J, Case UDI/GTIN: 40195327090808, Unit UDI/GTIN: 10195327090807, Lot Number: 22JDB038,22IDA739; j. NASAL, Item Number: CDS984899G, Case UDI/GTIN: 40193489983822, Unit UDI/GTIN: 10193489983821, Lot Number: 22IBC505; k. ENT SET UP CDS, Item Number: CDS985421G, Case UDI/GTIN: 40193489319300, Unit UDI/GTIN: 10193489319309, Lot Number: 22KBG050,22HBX042; l. MINOR ENT SINUS PACK-LF, Item Number: DYNJ0101278F, Case UDI/GTIN: 40193489352352, Unit UDI/GTIN: 10193489352351, Lot Number: 22HDC403; m. MAJOR EAR PACK-LF, Item Number: DYNJ0101314C, Case UDI/GTIN: 40193489451093, Unit UDI/GTIN: 10193489451092, Lot Number: 22JDA679,22HDC440; n. THORACOTOMY HARPER PACK-LF, Item Number: DYNJ0161795C, Case UDI/GTIN: 40889942216629, Unit UDI/GTIN: 10889942216628, Lot Number: 22IDB179; o. FESS NSR PACK-LF, Item Number: DYNJ0381496I, Case UDI/GTIN: 40193489475310, Unit UDI/GTIN: 10193489475319, Lot Number: 22JBH235; p. ENT BASIC PACK-LF, Item Number: DYNJ0387711D, Case UDI/GTIN: 40195327270156, Unit UDI/GTIN: 10195327270155, Lot Number: 22JMI201; q. HEAD & NECK-LF, Item Number: DYNJ04437J, Case UDI/GTIN: 40193489274494, Unit UDI/GTIN: 10193489274493, Lot Number: 22JMI207; r. ENT PACK-LF, Item Number: DYNJ04591F, Case UDI/GTIN: 40193489551434, Unit UDI/GTIN: 10193489551433, Lot Number: 22JMH877; s. SINOSCOPY-LF, Item Number: DYNJ06621D, Case UDI/GTIN: 40888277854698, Unit UDI/GTIN: 10888277854697, Lot Number: 22JBM104,22HBX999; t. MAJOR HEAD/NECK PACK-LF, Item Number: DYNJ0826705N, Case UDI/GTIN: 40193489265683, Unit UDI/GTIN: 10193489265682, Lot Number: 22JMD563,22JMD586; u. NECK PACK, Item Number: DYNJ13175, Case UDI/GTIN: 40195327215782, Unit UDI/GTIN: 10195327215781, Lot Number: 22JBG041; v. HEAD & NECK PACK, Item Number: DYNJ14069B, Case UDI/GTIN: 40884389223025, Unit UDI/GTIN: 10884389223024, Lot Number: 22JBI051,22IBQ751,22IBB059; w. HEAD & NECK TRAY, Item Number: DYNJ15653J, Case UDI/GTIN: 40193489767996, Unit UDI/GTIN: 10193489767995, Lot Number: 22JBE697; x. ENT LAW PACK-LF, Item Number: DYNJ16428L, Case UDI/GTIN: 40195327084821, Unit UDI/GTIN: 10195327084820, Lot Number: 22JMD569,22HMB943; y. ENT PACK, Item Number: DYNJ17203I, Case UDI/GTIN: 40193489668170, Unit UDI/GTIN: 10193489668179, Lot Number: 22IDB986; z. NECK PACK, Item Number: DYNJ17213D, Case UDI/GTIN: 40193489668477, Unit UDI/GTIN: 10193489668476, Lot Number: 22JDA408; aa. NASAL PACK, Item Number: DYNJ17493G, Case UDI/GTIN: 40195327224425, Unit UDI/GTIN: 10195327224424, Lot Number: 22HBR581; bb. ENT PACK, Item Number: DYNJ19846J, Case UDI/GTIN: 40888277850997, Unit UDI/GTIN: 10888277850996, Lot Number: 22IBV046; cc. FREE FLAP PACK-LF, Item Number: DYNJ20495J, Case UDI/GTIN: 40195327024407, Unit UDI/GTIN: 10195327024406, Lot Number: 22JDA143; dd. TYMPANO MASTOID, Item Number: DYNJ21567A, Case UDI/GTIN: 40080196015345, Unit UDI/GTIN: 10080196015344, Lot Number: 22JBD171,22IBE475,22HBK016; ee. MINOR HEAD & NECK #40-RF, Item Number: DYNJ21948S, Case UDI/GTIN: 40195327104727, Unit UDI/GTIN: 10195327104726, Lot Number: 22JBB180,22JBC021; ff. EAR PACK, Item Number: DYNJ22136B, Case UDI/GTIN: 40193489228220, Unit UDI/GTIN: 10193489228229, Lot Number: 22KMA168; gg. E.N.T. TRAY, Item Number: DYNJ22357K, Case UDI/GTIN: 40193489926737, Unit UDI/GTIN: 10193489926736, Lot Number: 22KBB868,22JBE605,22IBD335,22HBJ735; hh. EAR PACK-LF, Item Number: DYNJ24092M, Case UDI/GTIN: 40195327024421, Unit UDI/GTIN: 10195327024420, Lot Number: 22IDA807; ii. BASIC ENT PACK-LF, Item Number: DYNJ24912K, Case UDI/GTIN: 40193489992862, Unit UDI/GTIN: 10193489992861, Lot Number: 22IBL139,22HBV866,22HBU453,22HBT633,22HBP897; jj. PLASTIC HEAD & NECK PACK, Item Number: DYNJ24941M, Case UDI/GTIN: 40889942176329, Unit UDI/GTIN: 10889942176328, Lot Number: 22IDC167; kk. EAR TRAY #10-RF, Item Number: DYNJ27428R, Case UDI/GTIN: 40195327114900, Unit UDI/GTIN: 10195327114909, Lot Number: 22JBI743; ll. HEAD & NECK ENT PACK-RF-LF, Item Number: DYNJ30604P, Case UDI/GTIN: 40193489962834, Unit UDI/GTIN: 10193489962833, Lot Number: 22IBU329,22IBU962; mm. ENT PACK, Item Number: DYNJ30988C, Case UDI/GTIN: 40889942715719, Unit UDI/GTIN: 10889942715718, Lot Number: 22IBI164; nn. ENT PACK-LF, Item Number: DYNJ31584I, Case UDI/GTIN: 40193489504416, Unit UDI/GTIN: 10193489504415, Lot Number: 22JME741,22IMG343; oo. NASAL/SEPTO PACK, Item Number: DYNJ32099, Case UDI/GTIN: 40884389092911, Unit UDI/GTIN: 10884389092910, Lot Number: 22KBA569; pp. OSC FACE LIFT PK, Item Number: DYNJ32855B, Case UDI/GTIN: 40889942465218, Unit UDI/GTIN: 10889942465217, Lot Number: 22IBH454; qq. RRMC NASAL PACK, Item Number: DYNJ33396G, Case UDI/GTIN: 40193489914574, Unit UDI/GTIN: 10193489914573, Lot Number: 22JMD009; rr. ENT PACK, Item Number: DYNJ33698D, Case UDI/GTIN: 40889942689355, Unit UDI/GTIN: 10889942689354, Lot Number: 22JBY709,22IBF415; ss. HENRYS ENT PACK, Item Number: DYNJ34093F, Case UDI/GTIN: 40193489274685, Unit UDI/GTIN: 10193489274684, Lot Number: 22JMC221; tt. ENT, Item Number: DYNJ34426I, Case UDI/GTIN: 40193489224703, Unit UDI/GTIN: 10193489224702, Lot Number: 22JMA985; uu. FACE AND NASAL PACK, Item Number: DYNJ35554B, Case UDI/GTIN: 40195327097869, Unit UDI/GTIN: 10195327097868, Lot Number: 22IBQ641; vv. NASAL PACK, Item Number: DYNJ35803A, Case UDI/GTIN: 40889942557210, Unit UDI/GTIN: 10889942557219, Lot Number: 22JBE657; ww. ENT PACK, Item Number: DYNJ36516, Case UDI/GTIN: 40884389544113, Unit UDI/GTIN: 10884389544112, Lot Number: 22HBS907; xx. SINUS ENDOSCOPY-LF, Item Number: DYNJ36720D, Case UDI/GTIN: 40195327148684, Unit UDI/GTIN: 10195327148683, Lot Number: 22JBA686; yy. OSC NASAL-NOSE PACK-LF, Item Number: DYNJ37383C, Case UDI/GTIN: 40889942465256, Unit UDI/GTIN: 10889942465255, Lot Number: 22JBA361,22HBN245,22HBN978,22HBL526; zz. ENT PACK, Item Number: DYNJ38321D, Case UDI/GTIN: 40195327103591, Unit UDI/GTIN: 10195327103590, Lot Number: 22JBQ451; aaa. FES PACK - LF, Item Number: DYNJ38730C, Case UDI/GTIN: 40195327100316, Unit UDI/GTIN: 10195327100315, Lot Number: 22JMC574; bbb. HEAD AND NECK PACK, Item Number: DYNJ38880D, Case UDI/GTIN: 40193489997331, Unit UDI/GTIN: 10193489997330, Lot Number: 22JMA087; ccc. SCRIPPS SW ENT PACK, Item Number: DYNJ39829D, Case UDI/GTIN: 40195327176571, Unit UDI/GTIN: 10195327176570, Lot Number: 22IMI295,22HME428; ddd. SCRIPPS SW EAR PACK-LF, Item Number: DYNJ39858B, Case UDI/GTIN: 40195327179466, Unit UDI/GTIN: 10195327179465, Lot Number: 22JMA176; eee. HL ENT PACK, Item Number: DYNJ40360D, Case UDI/GTIN: 40889942697176, Unit UDI/GTIN: 10889942697175, Lot Number: 22JBL587,22IBS429,22IBU440; fff. CAROTID ENDARTECTOMY PK, Item Number: DYNJ40386B, Case UDI/GTIN: 40889942215769, Unit UDI/GTIN: 10889942215768, Lot Number: 22IBP925; ggg. EAR PACK, Item Number: DYNJ40401B, Case UDI/GTIN: 40193489231527, Unit UDI/GTIN: 10193489231526, Lot Number: 22JBI621,22HBS976,22HBK587; hhh. ENT FREE FLAP, Item Number: DYNJ40403D, Case UDI/GTIN: 40193489373531, Unit UDI/GTIN: 10193489373530, Lot Number: 22IBU477,22HBT008; iii. HEAD AND NECK PACK, Item Number: DYNJ40411A, Case UDI/GTIN: 40889942216094, Unit UDI/GTIN: 10889942216093, Lot Number: 22JBI783,22IBG980,22HBI781; jjj. TRACH PACK, Item Number: DYNJ40431A, Case UDI/GTIN: 40889942215691, Unit UDI/GTIN: 10889942215690, Lot Number: 22JBP822,22HBS909; kkk. HL EAR PACK, Item Number: DYNJ40560A, Case UDI/GTIN: 40889942529897, Unit UDI/GTIN: 10889942529896, Lot Number: 22HBZ367; lll. NASAL SINUS ENDO PK, Item Number: DYNJ41024C, Case UDI/GTIN: 40889942233466, Unit UDI/GTIN: 10889942233465, Lot Number: 22IBS024; mmm. ENT PACK, Item Number: DYNJ41060A, Case UDI/GTIN: 40195327025428, Unit UDI/GTIN: 10195327025427, Lot Number: 22IBQ559,22IBL826,22IBL050; nnn. HEAD AND NECK PACK, Item Number: DYNJ41270B, Case UDI/GTIN: 40193489789080, Unit UDI/GTIN: 10193489789089, Lot Number: 22JMB156,22JMB478,22JMA301; ooo. ENT PACK, Item Number: DYNJ41327C, Case UDI/GTIN: 40193489923156, Unit UDI/GTIN: 10193489923155, Lot Number: 22JBW436,22HBI717; ppp. HEAD AND NECK PACK, Item Number: DYNJ42004B, Case UDI/GTIN: 40888277918239, Unit UDI/GTIN: 10888277918238, Lot Number: 22JMC585; qqq. ASC HEAD & NECK PACK, Item Number: DYNJ42019B, Case UDI/GTIN: 40888277938329, Unit UDI/GTIN: 10888277938328, Lot Number: 22IBM163,22HBL313; rrr. ENT PACK, Item Number: DYNJ42228B, Case UDI/GTIN: 40193489878975, Unit UDI/GTIN: 10193489878974, Lot Number: 22IMB508; sss. DEACONESS HEAD AND NECK PACK, Item Number: DYNJ42242, Case UDI/GTIN: 40884389921280, Unit UDI/GTIN: 10884389921289, Lot Number: 22HBY134,22HBZ333; ttt. ENT PACK, Item Number: DYNJ42564B, Case UDI/GTIN: 40193489685047, Unit UDI/GTIN: 10193489685046, Lot Number: 22IBC952; uuu. BEC MOHS PACK, Item Number: DYNJ43111G, Case UDI/GTIN: 40195327007615, Unit UDI/GTIN: 10195327007614, Lot Number: 22JBK014; vvv. PK,ENT-EAR, Item Number: DYNJ43700A, Case UDI/GTIN: 40193489332194, Unit UDI/GTIN: 10193489332193, Lot Number: 22HBS025,22HBP684; www. SVMMC HEAD AND NECK PACK, Item Number: DYNJ43776G, Case UDI/GTIN: 40193489989718, Unit UDI/GTIN: 10193489989717, Lot Number: 22JBG530,22JBD640; xxx. PK, ENT, Item Number: DYNJ43875B, Case UDI/GTIN: 40193489427876, Unit UDI/GTIN: 10193489427875, Lot Number: 22JBM105,22IBC196; yyy. HEAD AND NECK PACK, Item Number: DYNJ44019B, Case UDI/GTIN: 40193489795081, Unit UDI/GTIN: 10193489795080, Lot Number: 22HBY533,22HBM204; zzz. FESS PACK, Item Number: DYNJ44080A, Case UDI/GTIN: 40888277279774, Unit UDI/GTIN: 10888277279773, Lot Number: 22IBV695; aaaa. PK,ENT-SINUS, Item Number: DYNJ45036D, Case UDI/GTIN: 40193489259903, Unit UDI/GTIN: 10193489259902, Lot Number: 22JBF806,22HBG764; bbbb. NASAL/HEAD & NECK PACK, Item Number: DYNJ45078C, Case UDI/GTIN: 40195327045204, Unit UDI/GTIN: 10195327045203, Lot Number: 22JBL812,22JBL819; cccc. ENT PACK, Item Number: DYNJ45175B, Case UDI/GTIN: 40889942485216, Unit UDI/GTIN: 10889942485215, Lot Number: 22HLA901; dddd. ENT PACK, Item Number: DYNJ45260B, Case UDI/GTIN: 40193489852449, Unit UDI/GTIN: 10193489852448, Lot Number: 22JBU804; eeee. MAJOR ENT PACK, Item Number: DYNJ45576B, Case UDI/GTIN: 40195327059201, Unit UDI/GTIN: 10195327059200, Lot Number: 22JBD150,22IBS180; ffff. ENT NECK MMC PACK, Item Number: DYNJ46091G, Case UDI/GTIN: 40193489496452, Unit UDI/GTIN: 10193489496451, Lot Number: 22HDB941; gggg. HEAD AND NECK PACK, Item Number: DYNJ46216I, Case UDI/GTIN: 40195327160341, Unit UDI/GTIN: 10195327160340, Lot Number: 22JBE614,22JBE616,22IBI293; hhhh. HEAD AND NECK PACK, Item Number: DYNJ46486B, Case UDI/GTIN: 40193489472159, Unit UDI/GTIN: 10193489472158, Lot Number: 22IBH413; iiii. HEAD AND NECK PACK, Item Number: DYNJ46509G, Case UDI/GTIN: 40195327001002, Unit UDI/GTIN: 10195327001001, Lot Number: 22HMD805; jjjj. ORAL PACK, Item Number: DYNJ46541J, Case UDI/GTIN: 40195327067909, Unit UDI/GTIN: 10195327067908, Lot Number: 22HME315; kkkk. HMT THORACOSCOPY PACK, Item Number: DYNJ47230K, Case UDI/GTIN: 40193489839259, Unit UDI/GTIN: 10193489839258, Lot Number: 22IBF197; llll. GU PACK, Item Number: DYNJ47244B, Case UDI/GTIN: 40888277896445, Unit UDI/GTIN: 10888277896444, Lot Number: 22JBE709; mmmm. HEAD NECKPACK (HNSJC)227-LF, Item Number: DYNJ47489B, Case UDI/GTIN: 40193489836821, Unit UDI/GTIN: 10193489836820, Lot Number: 22JMD474; nnnn. HEAD AND NECK PLUS I PACK, Item Number: DYNJ47635B, Case UDI/GTIN: 40193489731003, Unit UDI/GTIN: 10193489731002, Lot Number: 22HBI260; oooo. NASAL PACK, Item Number: DYNJ47753D, Case UDI/GTIN: 40193489859325, Unit UDI/GTIN: 10193489859324, Lot Number: 22IMI004; pppp. HEAD & NECK PACK-RFD-LF, Item Number: DYNJ47765J, Case UDI/GTIN: 40193489768085, Unit UDI/GTIN: 10193489768084, Lot Number: 22IMG240,22HMD477; qqqq. ENT PACK, Item Number: DYNJ47847C, Case UDI/GTIN: 40889942234296, Unit UDI/GTIN: 10889942234295, Lot Number: 22HBM628; rrrr. ENT/H&N PACK, Item Number: DYNJ48442D, Case UDI/GTIN: 40888277764508, Unit UDI/GTIN: 10888277764507, Lot Number: 22HMC400; ssss. C-SECTION PACK, Item Number: DYNJ48455A, Case UDI/GTIN: 40889942754497, Unit UDI/GTIN: 10889942754496, Lot Number: 22HBR925,22HBR422,22HBG075; tttt. ENT PACK, Item Number: DYNJ48595, Case UDI/GTIN: 40888277915184, Unit UDI/GTIN: 10888277915183, Lot Number: 22JBE666; uuuu. ENT PACK, Item Number: DYNJ48856D, Case UDI/GTIN: 40889942975472, Unit UDI/GTIN: 10889942975471, Lot Number: 22IBC410,22HBX258; vvvv. ENT PACK, Item Number: DYNJ48856F, Case UDI/GTIN: 40195327260188, Unit UDI/GTIN: 10195327260187, Lot Number: 22JBC693; wwww. NASAL ENT PACK, Item Number: DYNJ49356, Case UDI/GTIN: 40888277846785, Unit UDI/GTIN: 10888277846784, Lot Number: 22IBF462,22IBB028; xxxx. SINUS PACK, Item Number: DYNJ50110B, Case UDI/GTIN: 40889942794943, Unit UDI/GTIN: 10889942794942, Lot Number: 22HME087; yyyy. HEAD/NECK PACK, Item Number: DYNJ50297A, Case UDI/GTIN: 40889942302582, Unit UDI/GTIN: 10889942302581, Lot Number: 22IBK191,22HBZ267; zzzz. ENT PACK, Item Number: DYNJ50502G, Case UDI/GTIN: 40888277765901, Unit UDI/GTIN: 10888277765900, Lot Number: 22JBF009,22JBD205,22HBR406; aaaaa. NASAL PACK, Item Number: DYNJ50533C, Case UDI/GTIN: 40193489896764, Unit UDI/GTIN: 10193489896763, Lot Number: 22HBM477; bbbbb. FESS PACK, Item Number: DYNJ50596B, Case UDI/GTIN: 40193489864909, Unit UDI/GTIN: 10193489864908, Lot Number: 22IBK682; ccccc. NASAL SEPTOPLASTY PACK, Item Number: DYNJ50960I, Case UDI/GTIN: 40195327065639, Unit UDI/GTIN: 10195327065638, Lot Number: 22HBP168; ddddd. ENT PACK, Item Number: DYNJ51934A, Case UDI/GTIN: 40193489584777, Unit UDI/GTIN: 10193489584776, Lot Number: 22JMG827; eeeee. HEAD&NECK, Item Number: DYNJ52015, Case UDI/GTIN: 40889942233077, Unit UDI/GTIN: 10889942233076, Lot Number: 22IBL671; fffff. EAR PACK-LF, Item Number: DYNJ52043B, Case UDI/GTIN: 40195327096305, Unit UDI/GTIN: 10195327096304, Lot Number: 22JBV651; ggggg. HEAD AND NECK PACK-LF, Item Number: DYNJ52047B, Case UDI/GTIN: 40195327096060, Unit UDI/GTIN: 10195327096069, Lot Number: 22JBL899; hhhhh. EAR BASIC PACK, Item Number: DYNJ52099G, Case UDI/GTIN: 40195327035250, Unit UDI/GTIN: 10195327035259, Lot Number: 22JBW666,22JBH682; iiiii. HEAD AND NECK PACK, Item Number: DYNJ52101D, Case UDI/GTIN: 40195327079902, Unit UDI/GTIN: 10195327079901, Lot Number: 22IBR398; jjjjj. ENT/SEPTO PACK, Item Number: DYNJ52102C, Case UDI/GTIN: 40195327035267, Unit UDI/GTIN: 10195327035266, Lot Number: 22IBK213,22HBT012; kkkkk. ENT PACK, Item Number: DYNJ52641C, Case UDI/GTIN: 40195327125548, Unit UDI/GTIN: 10195327125547, Lot Number: 22JME346,22CBY373; lllll. HEAD & NECK PACK, Item Number: DYNJ52758F, Case UDI/GTIN: 40193489929479, Unit UDI/GTIN: 10193489929478, Lot Number: 22HBX064,22HBR162; mmmmm. HEAD AND NECK PACK, Item Number: DYNJ52867C, Case UDI/GTIN: 40195327048137, Unit UDI/GTIN: 10195327048136, Lot Number: 22IBQ656; nnnnn. ENT PACK, Item Number: DYNJ53413, Case UDI/GTIN: 40889942421085, Unit UDI/GTIN: 10889942421084, Lot Number: 22KBA262; ooooo. ENT PACK-LF, Item Number: DYNJ54443C, Case UDI/GTIN: 40889942925637, Unit UDI/GTIN: 10889942925636, Lot Number: 22IBG086; ppppp. ENT PACK-LF, Item Number: DYNJ54911B, Case UDI/GTIN: 40193489317054, Unit UDI/GTIN: 10193489317053, Lot Number: 22JBK448,22IBO920,22HBR955; qqqqq. HL DR PETERS ENT PACK, Item Number: DYNJ55161, Case UDI/GTIN: 40889942530640, Unit UDI/GTIN: 10889942530649, Lot Number: 22JBQ711,22IBL566; rrrrr. RHINO/SEPTO/FESS PACK, Item Number: DYNJ55955F, Case UDI/GTIN: 40195327023660, Unit UDI/GTIN: 10195327023669, Lot Number: 22IBB402,22HBU443; sssss. HEAD & NECK, Item Number: DYNJ56352D, Case UDI/GTIN: 40193489891417, Unit UDI/GTIN: 10193489891416, Lot Number: 22HMF122; ttttt. THYROID/PARATHYROID PACK, Item Number: DYNJ56989B, Case UDI/GTIN: 40193489997423, Unit UDI/GTIN: 10193489997422, Lot Number: 22IDB856; uuuuu. HEAD AND NECK MINOR PACK, Item Number: DYNJ57500A, Case UDI/GTIN: 40193489997386, Unit UDI/GTIN: 10193489997385, Lot Number: 22JBG027,22JBD520,22JBE591; vvvvv. PK,ENT, Item Number: DYNJ57583, Case UDI/GTIN: 40889942755333, Unit UDI/GTIN: 10889942755332, Lot Number: 22IBF900; wwwww. ENT PACK, Item Number: DYNJ57639A, Case UDI/GTIN: 40193489985055, Unit UDI/GTIN: 10193489985054, Lot Number: 22JMC352; xxxxx. ENT PACK, Item Number: DYNJ58613, Case UDI/GTIN: 40889942872207, Unit UDI/GTIN: 10889942872206, Lot Number: 22HBU133; yyyyy. ENT PACK, Item Number: DYNJ58955, Case UDI/GTIN: 40889942913290, Unit UDI/GTIN: 10889942913299, Lot Number: 22JMF041; zzzzz. ENT NECK PACK, Item Number: DYNJ59339B, Case UDI/GTIN: 40193489912402, Unit UDI/GTIN: 10193489912401, Lot Number: 22HMC555; aaaaaa. ENT PACK, Item Number: DYNJ59447A, Case UDI/GTIN: 40193489707664, Unit UDI/GTIN: 10193489707663, Lot Number: 22IBE517; bbbbbb. NECK PACK, Item Number: DYNJ60653A, Case UDI/GTIN: 40195327100286, Unit UDI/GTIN: 10195327100285, Lot Number: 22HME148; cccccc. EAR TRAY, Item Number: DYNJ60743F, Case UDI/GTIN: 40193489221443, Unit UDI/GTIN: 10193489221442, Lot Number: 22IBD747; dddddd. HEAD & NECK PACK, Item Number: DYNJ61295B, Case UDI/GTIN: 40193489809139, Unit UDI/GTIN: 10193489809138, Lot Number: 22HBN475; eeeeee. HEAD & NECK PACK, Item Number: DYNJ61295C, Case UDI/GTIN: 40195327246915, Unit UDI/GTIN: 10195327246914, Lot Number: 22IBH189; ffffff. MHPB HEAD AND NECK PACK, Item Number: DYNJ62032B, Case UDI/GTIN: 40195327058280, Unit UDI/GTIN: 10195327058289, Lot Number: 22JBC723,22HBR741; gggggg. NASAL PACK, Item Number: DYNJ62057C, Case UDI/GTIN: 40195327038503, Unit UDI/GTIN: 10195327038502, Lot Number: 22JBW712; hhhhhh. ENT PACK, Item Number: DYNJ62476B, Case UDI/GTIN: 40193489899796, Unit UDI/GTIN: 10193489899795, Lot Number: 22HBY505; iiiiii. JHOC EAR TRAY, Item Number: DYNJ62763A, Case UDI/GTIN: 40193489755955, Unit UDI/GTIN: 10193489755954, Lot Number: 22JBG830; jjjjjj. JHOC HEAD TRAY, Item Number: DYNJ62764A, Case UDI/GTIN: 40193489755962, Unit UDI/GTIN: 10193489755961, Lot Number: 22IBR805,22HBY155; kkkkkk. ENT I, Item Number: DYNJ63781A, Case UDI/GTIN: 40195327213115, Unit UDI/GTIN: 10195327213114, Lot Number: 22HMC704; llllll. ENT SHARED, Item Number: DYNJ64782B, Case UDI/GTIN: 40195327217700, Unit UDI/GTIN: 10195327217709, Lot Number: 22JDB161,22HDC318; mmmmmm. ENT PACK, Item Number: DYNJ66178B, Case UDI/GTIN: 40193489986342, Unit UDI/GTIN: 10193489986341, Lot Number: 22JBE823,22HBM481; nnnnnn. EENT SPLIT PACK-NO GPAD, Item Number: DYNJ66249, Case UDI/GTIN: 40193489324755, Unit UDI/GTIN: 10193489324754, Lot Number: 22JBY465; oooooo. ENT PACK, Item Number: DYNJ66379, Case UDI/GTIN: 40193489347693, Unit UDI/GTIN: 10193489347692, Lot Number: 22HMF906; pppppp. HEAD & NECK PACK, Item Number: DYNJ66399, Case UDI/GTIN: 40193489351430, Unit UDI/GTIN: 10193489351439, Lot Number: 22HBO944; qqqqqq. NASAL PACK, Item Number: DYNJ66514, Case UDI/GTIN: 40193489359283, Unit UDI/GTIN: 10193489359282, Lot Number: 22JBG484; rrrrrr. ENT PACK, Item Number: DYNJ66570, Case UDI/GTIN: 40193489360630, Unit UDI/GTIN: 10193489360639, Lot Number: 22IBU414; ssssss. ENT PACK, Item Number: DYNJ67751B, Case UDI/GTIN: 40195327029686, Unit UDI/GTIN: 10195327029685, Lot Number: 22JMF955; tttttt. ENT PACK, Item Number: DYNJ67775A, Case UDI/GTIN: 40193489996259, Unit UDI/GTIN: 10193489996258, Lot Number: 22HBU117; uuuuuu. ENT PACK, Item Number: DYNJ67824A, Case UDI/GTIN: 40193489495004, Unit UDI/GTIN: 10193489495003, Lot Number: 22IBR987; vvvvvv. ENT PACK-LF, Item Number: DYNJ67992, Case UDI/GTIN: 40193489462624, Unit UDI/GTIN: 10193489462623, Lot Number: 22IBJ809,22HBM177; wwwwww. ENT I-LF, Item Number: DYNJ68364A, Case UDI/GTIN: 40195327024513, Unit UDI/GTIN: 10195327024512, Lot Number: 22JBE689; xxxxxx. MAJOR HEAD AND NECK PACK, Item Number: DYNJ68819A, Case UDI/GTIN: 40195327159536, Unit UDI/GTIN: 10195327159535, Lot Number: 22HBN411; yyyyyy. HEAD AND NECK PACK, Item Number: DYNJ68872A, Case UDI/GTIN: 40195327181391, Unit UDI/GTIN: 10195327181390, Lot Number: 22JBO613; zzzzzz. FACE AND NECK, Item Number: DYNJ69446A, Case UDI/GTIN: 40195327264810, Unit UDI/GTIN: 10195327264819, Lot Number: 22KBA528; aaaaaaa. ENT PACK, Item Number: DYNJ69486, Case UDI/GTIN: 40193489948579, Unit UDI/GTIN: 10193489948578, Lot Number: 22HME759; bbbbbbb. ENT PACK, Item Number: DYNJ69558A, Case UDI/GTIN: 40195327225170, Unit UDI/GTIN: 10195327225179, Lot Number: 22IBP115,22HBT948; ccccccc. ENT BASIC PACK-LF, Item Number: DYNJ69587A, Case UDI/GTIN: 40195327040391, Unit UDI/GTIN: 10195327040390, Lot Number: 22HME707; ddddddd. ENT PACK-LF, Item Number: DYNJ69688, Case UDI/GTIN: 40193489969871, Unit UDI/GTIN: 10193489969870, Lot Number: 22JBE810,22HBI625; eeeeeee. PK, ENT-H&N, Item Number: DYNJ69851, Case UDI/GTIN: 40193489985857, Unit UDI/GTIN: 10193489985856, Lot Number: 22JME416,22HMH023; fffffff. ENT PACK, Item Number: DYNJ69890A, Case UDI/GTIN: 40195327235124, Unit UDI/GTIN: 10195327235123, Lot Number: 22IBR761,22HBU119; ggggggg. SPRINGS HEAD AND NECK PACK, Item Number: DYNJ69930, Case UDI/GTIN: 40193489997775, Unit UDI/GTIN: 10193489997774, Lot Number: 22IMI536,22HME709; hhhhhhh. ENDO SINUS PACK, Item Number: DYNJ69950A, Case UDI/GTIN: 40195327175703, Unit UDI/GTIN: 10195327175702, Lot Number: 22IBO306; iiiiiii. HEAD/NECK PACK, Item Number: DYNJ81402, Case UDI/GTIN: 40195327116768, Unit UDI/GTIN: 10195327116767, Lot Number: 22JBT150,22EBF640; jjjjjjj. ENT/SINUS PACK-LF, Item Number: DYNJ81820, Case UDI/GTIN: 40195327147250, Unit UDI/GTIN: 10195327147259, Lot Number: 22JBX949; kkkkkkk. ENT PACK, Item Number: DYNJ82137, Case UDI/GTIN: 40195327176670, Unit UDI/GTIN: 10195327176679, Lot Number: 22HBF358; lllllll. NASAL PACK, Item Number: DYNJ82476, Case UDI/GTIN: 40195327197217, Unit UDI/GTIN: 10195327197216, Lot Number: 22HBR242; mmmmmmm. ENT PACK, Item Number: DYNJ82492, Case UDI/GTIN: 40195327197484, Unit UDI/GTIN: 10195327197483, Lot Number: 22JBR187,22HBF736; nnnnnnn. ORAL PLASTIC FACIAL PACK, Item Number: DYNJ82506, Case UDI/GTIN: 40195327198313, Unit UDI/GTIN: 10195327198312, Lot Number: 22HBI367; ooooooo. ENT HEAD NECK PACK, Item Number: DYNJ82508, Case UDI/GTIN: 40195327198337, Unit UDI/GTIN: 10195327198336, Lot Number: 22HBH557; ppppppp. THYROIDECTOMY PACK, Item Number: DYNJ82520, Case UDI/GTIN: 40195327198368, Unit UDI/GTIN: 10195327198367, Lot Number: 22IBF364; qqqqqqq. MINOR ORL PACK, Item Number: DYNJ82563, Case UDI/GTIN: 40195327197996, Unit UDI/GTIN: 10195327197995, Lot Number: 22HBR212; rrrrrrr. EAR CUSTOM PACK, Item Number: DYNJ82564, Case UDI/GTIN: 40195327198009, Unit UDI/GTIN: 10195327198008, Lot Number: 22HBQ040; sssssss. MG NS ENT PACK, Item Number: DYNJ82590, Case UDI/GTIN: 40195327198818, Unit UDI/GTIN: 10195327198817, Lot Number: 22HBS185; ttttttt. HEAD AND NECK PACK, Item Number: DYNJ82641, Case UDI/GTIN: 40195327199402, Unit UDI/GTIN: 10195327199401, Lot Number: 22IBF695; uuuuuuu. ENT PACK, Item Number: DYNJ83139, Case UDI/GTIN: 40195327233717, Unit UDI/GTIN: 10195327233716, Lot Number: 22JBV408; vvvvvvv. MAJOR ENT PACK, Item Number: DYNJ83214, Case UDI/GTIN: 40195327245550, Unit UDI/GTIN: 10195327245559, Lot Number: 22JMD344; wwwwwww. ENT, Item Number: DYNJ901051F, Case UDI/GTIN: 40195327110803, Unit UDI/GTIN: 10195327110802, Lot Number: 22JBR735,22JBD787; xxxxxxx. NASAL EAR, Item Number: DYNJ901679F, Case UDI/GTIN: 40193489812238, Unit UDI/GTIN: 10193489812237, Lot Number: 22JBQ036; yyyyyyy. NASAL-LF, Item Number: DYNJ901749F, Case UDI/GTIN: 40193489604352, Unit UDI/GTIN: 10193489604351, Lot Number: 22IDB506; zzzzzzz. LARGE ENT, Item Number: DYNJ901761J, Case UDI/GTIN: 40195327091447, Unit UDI/GTIN: 10195327091446, Lot Number: 22KBE703,22JBA939,22IBS612; aaaaaaaa. EAR, Item Number: DYNJ901779J, Case UDI/GTIN: 40193489979740, Unit UDI/GTIN: 10193489979749, Lot Number: 22JBY312,22JBY313,22IBS613; bbbbbbbb. HEAD AND NECK, Item Number: DYNJ902108K, Case UDI/GTIN: 40193489969017, Unit UDI/GTIN: 10193489969016, Lot Number: 22IBP777; cccccccc. PAD ENT HEAD & NECK, Item Number: DYNJ902152F, Case UDI/GTIN: 40195327149216, Unit UDI/GTIN: 10195327149215, Lot Number: 22JBR424,22JBH326,22IBA638; dddddddd. FHT CVOR TAVR, Item Number: DYNJ902475B, Case UDI/GTIN: 40193489491471, Unit UDI/GTIN: 10193489491470, Lot Number: 22JBK902,22JBB350,22JBA002; eeeeeeee. MODULE NASAL NATALIE, Item Number: DYNJ903036I, Case UDI/GTIN: 40193489490092, Unit UDI/GTIN: 10193489490091, Lot Number: 22HBX971; ffffffff. ENT-LF, Item Number: DYNJ903253A, Case UDI/GTIN: 40889942632412, Unit UDI/GTIN: 10889942632411, Lot Number: 22JBW371; gggggggg. HEAD & NECK, Item Number: DYNJ903325L, Case UDI/GTIN: 40195327236473, Unit UDI/GTIN: 10195327236472, Lot Number: 22JBE300; hhhhhhhh. NASAL, Item Number: DYNJ903326J, Case UDI/GTIN: 40195327236480, Unit UDI/GTIN: 10195327236489, Lot Number: 22JBA437; iiiiiiii. HEAD & NECK, Item Number: DYNJ903472G, Case UDI/GTIN: 40195327146024, Unit UDI/GTIN: 10195327146023, Lot Number: 22KDA220; jjjjjjjj. T&A, Item Number: DYNJ903491G, Case UDI/GTIN: 40195327175598, Unit UDI/GTIN: 10195327175597, Lot Number: 22JDB890; kkkkkkkk. ENT HEAD & NECK, Item Number: DYNJ903679F, Case UDI/GTIN: 40195327182909, Unit UDI/GTIN: 10195327182908, Lot Number: 22HBT245,22HBR343; llllllll. HEAD AND NECK, Item Number: DYNJ903810C, Case UDI/GTIN: 40193489274135, Unit UDI/GTIN: 10193489274134, Lot Number: 22JBR487; mmmmmmmm. GENERAL THYROID, Item Number: DYNJ903998M, Case UDI/GTIN: 40195327220885, Unit UDI/GTIN: 10195327220884, Lot Number: 22IDB065; nnnnnnnn. ENT, Item Number: DYNJ904092C, Case UDI/GTIN: 40193489621717, Unit UDI/GTIN: 10193489621716, Lot Number: 22JDA348; oooooooo. HEAD AND NECK, Item Number: DYNJ904283B, Case UDI/GTIN: 40195327170241, Unit UDI/GTIN: 10195327170240, Lot Number: 22KBC286; pppppppp. ENT, Item Number: DYNJ904352D, Case UDI/GTIN: 40193489913478, Unit UDI/GTIN: 10193489913477, Lot Number: 22HBT177; qqqqqqqq. HEART, Item Number: DYNJ905208A, Case UDI/GTIN: 40889942910008, Unit UDI/GTIN: 10889942910007, Lot Number: 22JBQ793; rrrrrrrr. NASAL PACK, Item Number: DYNJ905563A, Case UDI/GTIN: 40193489800365, Unit UDI/GTIN: 10193489800364, Lot Number: 22KBD093; ssssssss. SINUS, Item Number: DYNJ905843D, Case UDI/GTIN: 40195327081066, Unit UDI/GTIN: 10195327081065, Lot Number: 22JBR673,22JBK495; tttttttt. HEAD&NECK, Item Number: DYNJ906948A, Case UDI/GTIN: 40195327128273, Unit UDI/GTIN: 10195327128272, Lot Number: 22JBP985,22IBE696; uuuuuuuu. ENT, Item Number: DYNJ907318, Case UDI/GTIN: 40193489387699, Unit UDI/GTIN: 10193489387698, Lot Number: 22HBS474,22HBN631; vvvvvvvv. EAR, Item Number: DYNJ907924C, Case UDI/GTIN: 40195327240029, Unit UDI/GTIN: 10195327240028, Lot Number: 22JBQ062,22HBW267; wwwwwwww. EENT, Item Number: DYNJ907925B, Case UDI/GTIN: 40195327173181, Unit UDI/GTIN: 10195327173180, Lot Number: 22JBL421,22JBK767,22JBE516,22IBI257,22HBR344; xxxxxxxx. EAR, Item Number: DYNJ909049, Case UDI/GTIN: 40195327257782, Unit UDI/GTIN: 10195327257781, Lot Number: 22JBR831,22JBE934; yyyyyyyy. ENT I-LF, Item Number: DYNJS0702, Case UDI/GTIN: 40080196798729, Unit UDI/GTIN: 10080196798728, Lot Number: 22JBH268,22IBN852,22IBF769; zzzzzzzz. ENT II-LF, Item Number: DYNJS0703, Case UDI/GTIN: 40080196597520, Unit UDI/GTIN: 10080196597529, Lot Number: 22JBJ174,22IBG858,22HBN515; aaaaaaaaa. HEAD AND NECK PACK, Item Number: DYNJS3068, Case UDI/GTIN: 40888277058294, Unit UDI/GTIN: 10888277058293, Lot Number: 22JBH755,22HBQ646; bbbbbbbbb. HEAD AND NECK PPH STD PACK-LF, Item Number: PHS184745F, Case UDI/GTIN: 40193489636681, Unit UDI/GTIN: 10193489636680, Lot Number: 22HBV665; ccccccccc. ENT PACK-LF, Item Number: PHS408470C, Case UDI/GTIN: 40195327126330, Unit UDI/GTIN: 10195327126339, Lot Number: 22HBF930; ddddddddd. ENT PACK-LF, Item Number: PHS408470D, Case UDI/GTIN: 40195327250639, Unit UDI/GTIN: 10195327250638, Lot Number: 22IBQ906

Product
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
9,079 cases (27,563 units)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Recall date
February 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls