Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 23, 2024 | CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate packa... | Product failed sterility testing. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 22, 2024 | Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 i... | Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. | Class II | Parker Laboratories, Inc. |
| Jan 22, 2024 | VITROS 5600 Integrated System (New and Refurbished) | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 22, 2024 | LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- In... | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it shoul... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 22, 2024 | Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Loc... | Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter... | Class II | B. Braun Medical, Inc. |
| Jan 22, 2024 | Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component... | Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to pre... | Class II | Invacare Corporation |
| Jan 22, 2024 | Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model... | Potential interference with the anti-fall system. | Class II | SEDECAL SA |
| Jan 22, 2024 | VITROS XT7600 Integrated System | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 22, 2024 | Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. S... | Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter ... | Class II | B. Braun Medical, Inc. |
| Jan 22, 2024 | VITROS 3600 Immunodiagnostic System (New and Refurbished) | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... | Class II | Ortho-Clinical Diagnostics, Inc. |
| 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: 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: 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 | 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: 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 | 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: 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: 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: 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 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: 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 | GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catal... | Devices without transmural drainage holes may be mislabeled as devices with transmural drainage h... | Class II | W.L. Gore & Associates, Inc. |
| Jan 17, 2024 | ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 4169... | The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for... | Class II | ConvaTec, Inc |
| Jan 16, 2024 | BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078.... | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier du... | Class II | Maquet Medical Systems USA |
| Jan 16, 2024 | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be use... | Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used fo... | Class II | Olympus Corporation of the Americas |
| Jan 16, 2024 | InstaClear Lens Cleaner-indicated for use during routine diagnostic procedure... | Japanese IFU version had slightly different language and illustrations from the English IFU, whic... | Class II | Olympus Corporation of the Americas |
| Jan 16, 2024 | W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Mo... | 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. Th... | Class II | W&H DENTALWERK BUERMOOS GMBH |
| Jan 16, 2024 | Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 7... | The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier du... | Class II | Maquet Medical Systems USA |
| Jan 15, 2024 | Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) | When using those products you may experience difficulties to extend or retract the laser fiber, a... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Jan 15, 2024 | IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Ster... | The kits contain saline flush syringes which were recalled by the supplier. | Class II | Medical Action Industries, Inc. 306 |
| Jan 15, 2024 | Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) | When using those products you may experience difficulties to extend or retract the laser fiber, a... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Jan 15, 2024 | Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) | When using those products you may experience difficulties to extend or retract the laser fiber, a... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Jan 12, 2024 | 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with u... | 3M has added the following cautionary statement regarding the use of the product: "Caution - T... | Class II | 3M Company - Health Care Business |
| Jan 12, 2024 | 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with u... | 3M has added the following cautionary statement regarding the use of the product: "Caution - T... | Class II | 3M Company - Health Care Business |
| Jan 11, 2024 | Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide... | The device has a grip detail (right angle latch) out of specification causing the bur to not adeq... | Class II | Brasseler USA I Lp |
| Jan 11, 2024 | Colonoscope, Model Number PCF-HQ190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lu... | European version of microcatheter were distributed within US which contain a different "Indicatio... | Class II | Micro Therapeutics, Inc. |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190TL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lu... | European version of microcatheter were distributed within US which contain a different "Indicatio... | Class II | Micro Therapeutics, Inc. |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-HQ190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-HQ190I. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-Q180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190DL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-Q180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-H180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 10, 2024 | Synapse PACS - Version 7.2.100 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
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.