FDAClass IIJuly 8, 2026

Otp5000 Thora/para Tray recall

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000…

Why was Otp5000 Thora/para Tray recalled?

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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?

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386

Product
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000…
Recalling firm
Bard Access Systems, Inc.
Quantity
9,500
Distribution
Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
Recall date
July 8, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls