Official recall records, one search

Check if a product is recalled

Recall check across official U.S. (CPSC, FDA, NHTSA), Canadian, EU RASFF, French (RappelConso) and Dutch (NVWA) records — including lot/batch, UPC barcode and vehicle lookup.

Try

Search by

Searches CPSC and FDA together. Meat, poultry and processed eggs are listed by USDA FSIS.

Recall briefings

Daily, weekly and monthly summaries of selected official safety notices.

Recent enforcement records

Recent CPSC and FDA enforcement records. Agency announcement dates may differ.

20 records
CPSCNov 5, 2026

Arlopu Recalls Slide Playsets Due to Risk of Serious Injury and Death from Head and Neck Entrapment Hazards

Why it was recalled
The recalled products contain multiple openings where a child’s torso can fit through the opening, but a child’s head cannot, posing a risk of serious injury and death due to head and neck entrapment hazards. Additionally, the basketball nets on the recalled products with model number KT-CS17 can come unhooked from the rim, forming a loop large enough for a child’s head, posing entanglement and strangulation hazards.
What to do
Consumers should stop using the Arlopu Slide Playsets immediately and store them away from children. Contact Arlopu for a free repair kit, which includes redesigned panels, basketball hoops and installation instructions. Consumers will be asked to provide a photo of the product showing the model number to [email protected]. Upon receipt of the photo, the firm will mail the free repair kit directly to consumers. Once the repair has been completed, consumers should write “RECALLED” with permanent marker on the removed components and dispose of the removed components.

Affected identifiers: Arlopu Slide Playsets

Firm / distribution: This recall involves Arlopu Slide Playsets with model numbers KT-CS17 and LY-31. The plastic playsets are designed for indoor or outdoor use and contain multiple activity components, including a slide and a basketball… View all

This recall involves Arlopu Slide Playsets with model numbers KT-CS17 and LY-31. The plastic playsets are designed for indoor or outdoor use and contain multiple activity components, including a slide and a basketball hoop. The playsets are available in tan, red, blue, yellow, gray and green. Model number KT-CS17 is printed on a label located on the underside of the elevated platform of the playset. Model LY-31 is printed on a label located on the upper back panel behind the slide of the playset.

Check this recall Open official notice
CPSCNov 5, 2026

Baby Brezza Enterprises Recalls SuperFast Sterilizer Dryers Due to Overheating and Burn Hazards

Why it was recalled
The recalled sterilizer dryers can overheat when plugged in and operating, posing a risk of injury from a burn hazard if the surface is handled.
What to do
Consumers should stop using the recalled sterilizer dryers immediately and contact Baby Brezza Enterprises for a free replacement sterilizer dryer, including shipping at no cost to the consumer. Consumers will be asked to register at https://babybrezza.com/pages/about?view=v3-recalls, complete the recall form, unplug the product, cut the power cord to destroy the sterilizer dryer and upload photos. Send photos of the model number on the label of the dryer the destroyed appliance and the return authorization number to [email protected]. After uploading the photos, consumers should dispose of the recalled sterilizer dryers in accordance with local and state ordinances.

Affected identifiers: SuperFast Sterilizer Dryers

Firm / distribution: This recall involves the SuperFast Sterilizer Dryer, a countertop appliance that uses a push-button control to sterilize and dry baby bottles, breast pump parts and accessories in ten minutes. The recalled units have… View all

This recall involves the SuperFast Sterilizer Dryer, a countertop appliance that uses a push-button control to sterilize and dry baby bottles, breast pump parts and accessories in ten minutes. The recalled units have model numbers BRZ0083, BRZ0154 and BRZ0156. The model number is printed on the product label located on the bottom of the unit.

Check this recall Open official notice
CPSCNov 5, 2026

Bose Recalls Lithium-Ion Battery Packs for S1 Pro and S1 Pro+ Bluetooth Speaker Systems Due to Risk of Injury from Fire and Overheating Hazards

Why it was recalled
The recalled lithium-ion battery packs can overheat and ignite, posing a risk of injury from fire and overheating hazards.
What to do
Consumers should remove the recalled battery packs installed in any S1 Pro and S1 Pro+ Portable Bluetooth Speaker Systems and stop using the battery packs immediately. Once the battery pack is removed, consumers may continue to use their S1 Pro and S1 Pro+ Portable Bluetooth Speakers while connected to AC power. Consumers will be asked to register and provide the affected battery pack’s serial number at www.support.bose.com/s1-battery-recall to receive a free replacement battery pack. For battery packs that are not installed in the speaker systems, consumers can simply view the serial number and provide that number to the website listed above. Consumers should dispose of the affected battery pack in accordance with local and state regulations. Note: Do not throw this recalled lithium-ion battery pack in the trash, the general recycling stream (e.g., street-level or curbside recycling bins), or used battery recycling boxes found at various retail and home improvement stores. Recalled lithium-ion batteries must be disposed of differently than other batteries because they present a greater risk of fire. Your municipal household hazardous waste (HHW) collection center may accept this recalled lithium-ion battery pack for disposal. Before taking your battery pack to a HHW collection center, contact that office ahead of time and ask whether it accepts recalled lithium-ion batteries. If it does not, contact your municipality for further guidance.

Affected identifiers: Bose S1 Pro System Battery Pack and S1 Pro+ System Battery Packs for use with Bose S1 Pro and Bose S1 Pro+ Speaker Systems.

Firm / distribution: This recall involves lithium-ion rechargeable battery packs intended for use with Bose S1 Pro and S1 Pro+ Portable Bluetooth Speaker Systems. The serial number of the battery packs included in this recall begins with any… View all

This recall involves lithium-ion rechargeable battery packs intended for use with Bose S1 Pro and S1 Pro+ Portable Bluetooth Speaker Systems. The serial number of the battery packs included in this recall begins with any one of the following six digits: 083723, 078352, 084105, 078591, 078592, 084106, or 086409. The 17-digit serial number for the battery pack is printed on a label placed at the bottom of the battery pack. The affected battery packs were sold with S1 Pro and S1 Pro+ Portable Bluetooth Speaker Systems and sold separately as accessories or replacement parts.

Check this recall Open official notice
CPSCNov 5, 2026

C.A.M.P. Recalls Mountain Ice Axes Due to Risk of Serious Injury or Death from Fall Hazard

Why it was recalled
A screw on the recalled mountain ice axes can loosen during use, causing the handle or pick to detach, posing a risk of serious injury or death from fall hazard.
What to do
Consumers should stop using the recalled mountain ice axes immediately and register at https://www.camp-usa.com/x-bolt-recall-102026 to receive a free repair kit. Consumers should have the model and batch number available, which can be found on the side of the axes’ shaft. Consumers can either contact C.A.M.P. for a free repair kit with instructions to repair the axes themselves or have the firm repair the ice axes. The firm will send the consumer a prepaid shipping label and packaging to return the recalled axes to the firm.

Affected identifiers: X-Dream, X-Dream Total Dry, X-All Mountain Hammer and X-All Mountain Adze

Firm / distribution: This recall includes X-Dream, X-Dream Total Dry, X-All Mountain Hammer and X-All Mountain Adze. These products are designed for vertical ice climbing. The batch number is located on the side of the shaft. “CAMP” is… View all

This recall includes X-Dream, X-Dream Total Dry, X-All Mountain Hammer and X-All Mountain Adze. These products are designed for vertical ice climbing. The batch number is located on the side of the shaft. “CAMP” is written in white lettering on the ice axes shaft. The recalled nut and bolt kit were also sold as an accessory item as model number 3641. Recalled Models and Batches • X-Dream (model: 3570): Batches 10/24, 07/25, 10/25, 12/25 • X-Dream Total Dry (model: 3609): Batches 10/24, 07/25, 11/25 • X-All Mountain Hammer (model: 3630): Batches 10/24, 09/25 • X-All Mountain Adze (model: 3631): Batches 10/24, 09/25 • Accessory Kit (nut and bolt) (model: 3641)

Check this recall Open official notice
CPSCNov 5, 2026

Gourmia Recalls 9-Slice Digital Air Fryer Ovens Due to Burn Hazard

Why it was recalled
The oven’s doors can unexpectedly close when bumped, posing a burn hazard to consumers retrieving hot food.
What to do
Consumers should stop using the recalled Ovens immediately and contact Gourmia for a free repair kit by mail. The repair kit will include an added doorstop and instructions on how to install.

Affected identifiers: Gourmia Stainless Steel Digital 9 Slice Digital Air Fryer Ovens

Firm / distribution: This recall involves Gourmia 9-SliceDigitalAir Fryer Ovens with model number GTF7530, and UPC Code 810002862779. The recalled ovens are stainless steel and have two spring-loaded glass front French doors with metal… View all

This recall involves Gourmia 9-SliceDigitalAir Fryer Ovens with model number GTF7530, and UPC Code 810002862779. The recalled ovens are stainless steel and have two spring-loaded glass front French doors with metal handles. The Ovens can be identified with model and UPC codes on packaging. The Model number GTF7530 and codes 3021 to 0126 can also be found on a label on back of the unit.

Check this recall Open official notice
CPSCNov 5, 2026

Jiastfeng Recalls HAUOMS Eight-drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units

Why it was recalled
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Jiastfeng for a full refund. Consumers will be asked to write in permanent marker “RECALLED” on the top, front and sides of the dresser, remove all drawers and send photos of the marked and disassembled dresser to [email protected]. Consumers should then dispose of the product.

Affected identifiers: HAUOMS Eight-drawer Dressers

Firm / distribution: This recall involves HAUOM-branded Eight-drawer dressers. The wooden black dressers measure about 27.6 inches wide, 15.8 inches long, 59.1 inches tall, and weigh about 112.4 pounds. "SKU: AJ_DJ504298_1" is printed on the… View all

This recall involves HAUOM-branded Eight-drawer dressers. The wooden black dressers measure about 27.6 inches wide, 15.8 inches long, 59.1 inches tall, and weigh about 112.4 pounds. "SKU: AJ_DJ504298_1" is printed on the product packaging.

Check this recall Open official notice
CPSCNov 5, 2026

Kikea Store Recalls X-VESOLJE Nursing Pillows Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing Pillows

Why it was recalled
The recalled nursing pillows violate the mandatory safety standards for nursing pillows because they can obstruct an infant’s breathing, posing a serious risk of injury or death from suffocation.
What to do
Consumers should stop using the recalled nursing pillows immediately and contact Kikea Store for a full refund. Consumers will be asked to cut the pillow in half after confirming the recalled pillow with the firm and send a photo of the destroyed pillow to [email protected]. Consumers should then dispose of the product.

Affected identifiers: X-VESOLJE Nursing Pillows

Firm / distribution: This recall involves X-VESOLJE Nursing Pillows, model number NP001. The nursing pillows are C-shaped and sold in white with leaves pattern, dark brown with multicolored feather pattern and multicolored puzzle piece… View all

This recall involves X-VESOLJE Nursing Pillows, model number NP001. The nursing pillows are C-shaped and sold in white with leaves pattern, dark brown with multicolored feather pattern and multicolored puzzle piece pattern. There are no markings or labels on the product.

Check this recall Open official notice
CPSCNov 5, 2026

Little Giant Recalls Ladders with Rapid Locks Due to Risk of Serious Injury from Fall Hazard

Why it was recalled
The ladders can suddenly retract if the Rapid Locks are not fully engaged, posing a fall hazard to consumers.
What to do
Consumers should stop using the recalled ladders immediately until they review the information at www.littlegiantladders.com/pages/recalls or via the QR code on the ladder and contact Little Giant for a repair kit containing warning labels and instructions. The additional instructions and labels, which should be affixed to the ladder, advise consumers to verify that their Rapid Locks are properly engaged before every use and to maintain their locks with lubrication. Consumers who follow the provided instructions and have a Rapid Lock that does not function properly after the application of lubrication should contact Little Giant for evaluation. If a lock does not function properly after this evaluation, the company will offer the choice of a replacement ladder of the same or equivalent model or a refund ranging from a depreciated value determined by date of purchase up to full purchase price for ladders purchased within the past 12 months.

Affected identifiers: Little Giant ladders with Rapid Locks

Firm / distribution: This recall involves Little Giant ladders with Rapid Locks. Rapid Locks are designed to insert into ladder rungs for the purpose of adjusting the ladder’s height. Rapid Locks are black or orange and are located on each… View all

This recall involves Little Giant ladders with Rapid Locks. Rapid Locks are designed to insert into ladder rungs for the purpose of adjusting the ladder’s height. Rapid Locks are black or orange and are located on each ladder leg. The affected models are Adjustable Fortress 2.0, Conquest 2.0, Dark Horse 2.0, Epic, King Kombo XT, Leveler, MegaLite, MegaLite+, Multi, Quantum and Vector. The brand name Little Giant and the model name are located on the side of the ladder. Only ladders without an orange rectangular “QC” sticker on the rail above one of the Rapid Locks are included in this recall.

Check this recall Open official notice
Class IIFDAOct 28, 2026

Jovy Gummy Worms Neon; packaged in 1lb plastic units. UPC 712199083411

Why it was recalled
undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)
What to do
The recall is ongoing. Follow the firm and FDA instructions.

Affected identifiers: lot: 6156 — 521 pounds

Firm / distribution: El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and… View all

El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.

Check this recall Open FDA enforcement record
Class IIFDAOct 28, 2026

Milk Chocolate Covered Raisins

Full product description

Milk Chocolate Covered Raisins; packaged in 1lb, 5lb, 20lb clear plastic units. No UPC

Why it was recalled
undeclared allergen ingredient (Milk, Soy)
What to do
The recall is ongoing. Follow the firm and FDA instructions.

Affected identifiers: lot: 630-715 — 61.37 pounds

Firm / distribution: El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and… View all

El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.

Check this recall Open FDA enforcement record
Class IIIFDAOct 28, 2026

Whole wheat flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC

Why it was recalled
undeclared allergen ingredient (Wheat)
What to do
The recall is ongoing. Follow the firm and FDA instructions.

Affected identifiers: none — 237 pounds

Firm / distribution: El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and… View all

El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.

Check this recall Open FDA enforcement record
Class IFDAOct 28, 2026

Special Red Almond Mole Powder

Full product description

Special Red Almond Mole Powder; packaged in 1lb, 5lb, 11lb clear plastic units. No UPC

Why it was recalled
undeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Almonds, Walnuts, Yellow#5, Yellow#6, Red#40, Blue#2)
What to do
The recall is ongoing. Follow the firm and FDA instructions.

Affected identifiers: Lot: 14250 — 1,277.91 pounds

Firm / distribution: El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and… View all

El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.

Check this recall Open FDA enforcement record
Class IIFDAOct 28, 2026

Fritura mixed dry fruit; packed in a clear plastic 1lb, 5lb, 25lb unit sizes. no UPC

Why it was recalled
undeclared allergen ingredient (Wheat, Yellow #5, Yellow #6)
What to do
The recall is ongoing. Follow the firm and FDA instructions.

Affected identifiers: no lot code — 134.59 pounds

Firm / distribution: El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and… View all

El Ruisenor De Mexico, Inc. — Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.

Check this recall Open FDA enforcement record
Class IIFDAOct 28, 2026

Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g)

Full product description

Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-520-35, Item # 88520, UPC 8 10147 88520 6

Why it was recalled
CGMP Deviations.
What to do
The recall is ongoing. Follow the firm and FDA instructions.

Affected identifiers: Lot# LWP250037221405, Exp Date: 07/04/2027; Lot# LWP250048151011, Exp Date: 11/11/2027; Lot# LWP250051162312A, Exp Date: 02/08/2028; Lot# LWP0054880903C, Exp Date: 04/30/2028. — 112,092 tubes

Firm / distribution: PRITAM INTERNATIONAL PRIVATE LIMITED — US Nationwide.

Check this recall Open FDA enforcement record
Class IFDAOct 28, 2026

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban…

Full product description

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.

Why it was recalled
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected identifiers: Lot #: 83449, Exp Date: 10/2026; 82682, Exp Date: 11/2026; 86714, 87302, 87560, Exp Date: 02/2027; 87753, 88401, Exp Date: 03/2027; 88614, 88836, Exp Date: 04/2027; 90220, Exp Date: 05/2027; 91216, 91219, Exp Date: 06/2027; 92004, 92006, Exp Date: 07/2027… View all

Lot #: 83449, Exp Date: 10/2026; 82682, Exp Date: 11/2026; 86714, 87302, 87560, Exp Date: 02/2027; 87753, 88401, Exp Date: 03/2027; 88614, 88836, Exp Date: 04/2027; 90220, Exp Date: 05/2027; 91216, 91219, Exp Date: 06/2027; 92004, 92006, Exp Date: 07/2027; 92009, 92596, 92782, 93107, 93329, Exp Date: 08/2027; 93890, Exp Date: 09/2027. — 18,991 vials

Firm / distribution: Par Health USA, LLC — Nationwide within the United States

Check this recall Open FDA enforcement record
Class IIFDAOct 28, 2026

evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g)

Full product description

evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3

Why it was recalled
CGMP Deviations.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected identifiers: Lot# LWP250038760606, Exp Date: 08/05/2027; Lot# LWP250045152409B, Exp Date: 10/07/2027; Lot# LWP250046862110B, Exp Date: 11/15/2027; Lot# LWP250047640511C, Exp Date: 12/15/2027; Lot# LWP250051172312B, Exp Date: 01/27/2028; Lot# LWP260052241401A, Exp Date… View all

Lot# LWP250038760606, Exp Date: 08/05/2027; Lot# LWP250045152409B, Exp Date: 10/07/2027; Lot# LWP250046862110B, Exp Date: 11/15/2027; Lot# LWP250047640511C, Exp Date: 12/15/2027; Lot# LWP250051172312B, Exp Date: 01/27/2028; Lot# LWP260052241401A, Exp Date: 03/20/2028; Lot# LWP260055532003, Exp Date: 04/12/2028. — 389,880 tubes

Firm / distribution: PRITAM INTERNATIONAL PRIVATE LIMITED — US Nationwide.

Check this recall Open FDA enforcement record
Class IIFDAOct 28, 2026

Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g)

Full product description

Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-004-40, Item # Product code: 32730, UPC 8 50048 32730 6.

Why it was recalled
CGMP Deviations.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected identifiers: Lot LWP240027561211, Exp Date: 12/07/2026; Lot # LWP250031970602, Exp Date: 02/28/2027; Lot # LWP250031980602, Exp Date: 03/11/2027; Lot # LWP250032381402, Exp Date: 03/17/2027; Lot # LWP250035680204, Exp Date: 04/30/2027; Lot # LWP250037682005A, Exp Date… View all

Lot LWP240027561211, Exp Date: 12/07/2026; Lot # LWP250031970602, Exp Date: 02/28/2027; Lot # LWP250031980602, Exp Date: 03/11/2027; Lot # LWP250032381402, Exp Date: 03/17/2027; Lot # LWP250035680204, Exp Date: 04/30/2027; Lot # LWP250037682005A, Exp Date: 06/08/2027; Lot # LWP250048601811, Exp Date: 12/09/2027; Lot # LWP250051382412, Exp Date: 01/09/2028; Lot # LWP260053652002, LWP260054222502, Exp Date: 03/31/2028. — 320,232 tubes

Firm / distribution: PRITAM INTERNATIONAL PRIVATE LIMITED — US Nationwide.

Check this recall Open FDA enforcement record
Class IIFDAOct 28, 2026

BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g)

Full product description

BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-885-42, Item # 88542, UPC 8 10147 88542 8

Why it was recalled
CGMP Deviations.
What to do
The recall is ongoing. Follow the firm and FDA instructions.

Affected identifiers: Lot # LWP250036560205A, Exp Date: 05/25/2027; Lot # LWP250038232805A, Exp Date: 06/19/2027; Lot # LWP0054880903D, Exp Date: 01/28/2028; Lot # LWP260056333003C, Exp Date: 06/04/2028. — 198,288 tubes

Firm / distribution: PRITAM INTERNATIONAL PRIVATE LIMITED — US Nationwide.

Check this recall Open FDA enforcement record
Class IIFDAOct 28, 2026

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290

Why it was recalled
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
What to do
The recall is ongoing. Follow the firm and FDA instructions.

Affected identifiers: Material Number: M001195290; UDI-DI: 08714729839408; Batch Numbers: 38362172, 38362173, 38530450, 38595659; — 42

Firm / distribution: Boston Scientific Cork, Ltd. — Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica… View all

Boston Scientific Cork, Ltd. — Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Check this recall Open FDA enforcement record
Class IIFDAOct 28, 2026

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440

Why it was recalled
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected identifiers: Material Number: M001195440; UDI-DI: 08714729839514; Batch Numbers: 38181961, 38198832, 38224582, 38259483, 38324070, 38460469, 38560455, 38560456, 38595654, 38649857, 38745194, 38745195, 38810586, 38810591, 38904805, 39092267, 39092272, 39143222, 40470259… View all

Material Number: M001195440; UDI-DI: 08714729839514; Batch Numbers: 38181961, 38198832, 38224582, 38259483, 38324070, 38460469, 38560455, 38560456, 38595654, 38649857, 38745194, 38745195, 38810586, 38810591, 38904805, 39092267, 39092272, 39143222, 40470259, 40478976, 40478977, 40492318, 40497671, 40497858, 40502038, 40502039; — 620

Firm / distribution: Boston Scientific Cork, Ltd. — Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica… View all

Boston Scientific Cork, Ltd. — Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Check this recall Open FDA enforcement record

Check exact lot numbers, model codes and official remedy instructions for major consumer notices.

All recall guides