Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 23, 2024 | stay-safe /Safe Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Catheter Ext. 6 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 18 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Adapter 4 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| 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 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| 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 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 | Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection ... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| 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 | 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 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 | 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 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| 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 | 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 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 | TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based... | Customers unable to use cartridges due to formatting error in expiration date which leads to swit... | Class III | STRATASYS LTD |
| Jan 19, 2024 | TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-bas... | Customers unable to use cartridges due to formatting error in expiration date which leads to swit... | Class III | STRATASYS LTD |
| 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 | TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based... | Customers unable to use cartridges due to formatting error in expiration date which leads to swit... | Class III | STRATASYS LTD |
| Jan 19, 2024 | TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-base... | Customers unable to use cartridges due to formatting error in expiration date which leads to swit... | Class III | STRATASYS LTD |
| 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 | 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 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 | TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-base... | Customers unable to use cartridges due to formatting error in expiration date which leads to swit... | Class III | STRATASYS LTD |
| 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 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 | MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: ... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... | Class I | Avanos Medical, Inc. |
| 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 | 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 | MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... | Class I | Avanos Medical, Inc. |
| 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 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 | 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 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 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 | 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 |
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.