Browse Device Recalls
3,179 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,179 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 3,179 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 24, 2024 | TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adult... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicl... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & acc... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation ... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing frac... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenera... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 23, 2024 | CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate packa... | Product failed sterility testing. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 19, 2024 | Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachno... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit ... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space o... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access t... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid ... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 19, 2024 | Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and... | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... | Class II | Integra LifeSciences Corp. |
| Jan 9, 2024 | DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic pr... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparo... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparos... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparos... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic pr... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | Howmedica Osteonics Corp. |
| Dec 22, 2023 | Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO | Sterility assurance for saline included in surgical kits cannot be guaranteed. | Class I | Windstone Medical Packaging, Inc. |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | Howmedica Osteonics Corp. |
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.