Browse Device Recalls
3,087 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,087 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,087 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 23, 2024 | Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Pr... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE C... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE TRACH BRUSH, Product Code 6225ST | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion PICC LINE SECUREMENT KIT, Product Code IVS565 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), P... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", P... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), ... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST718... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE #16 RUBBER BAND, Product Code EB16 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (S... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 22, 2024 | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference nu... | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Di... | Class II | Baxter Healthcare Corporation |
| Feb 21, 2024 | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | The reason for the recall is the failure of calibration and quality controls due to a manufacturi... | Class II | Abbott Laboratories |
| Feb 14, 2024 | STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 | Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer repo... | Class II | Baxter Healthcare Corporation |
| Feb 8, 2024 | microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 11... | Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated thi... | Class II | Landauer |
| Feb 8, 2024 | CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DE... | Class II | Baxter Healthcare Corporation |
| Feb 1, 2024 | In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange... | Products that were intended for export only which were not approved or registered in accordance w... | Class III | Abbott Molecular, Inc. |
| Feb 1, 2024 | In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, R... | Products that were intended for export only which were not approved or registered in accordance w... | Class III | Abbott Molecular, Inc. |
| Feb 1, 2024 | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This... | Products that were intended for export only which were not approved or registered in accordance w... | Class III | Abbott Molecular, Inc. |
| Jan 31, 2024 | Trumpet, Needle Guide, Cat# TMS-200 | The Ring on the Trump Needle Guide can detach when excessive pressure is applied. | Class II | Technicality Inc. |
| Jan 23, 2024 | CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate packa... | Product failed sterility testing. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, withou... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, R... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Dete... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, A... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 4, 2024 | Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe | Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testin... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 28, 2023 | Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.