Browse Device Recalls
2,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,419 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 2,419 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W ... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926 | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DY... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS9840... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF D... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ90500... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500 | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 15, 2024 | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... | Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. | Class II | Alcon Research, LLC |
| Mar 15, 2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TL... | Due to receiving information regarding difficulties with the insertion of a setscrew inside a scr... | Class II | SPINEART SA |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 11, 2024 | RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would... | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump... | Class II | Smith & Nephew Medical, Ltd. |
| Mar 11, 2024 | RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would... | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump... | Class II | Smith & Nephew Medical, Ltd. |
| Feb 29, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometri... | The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) ass... | Class II | Beckman Coulter, Inc. |
| Feb 26, 2024 | Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18... | Complaints have been received that the device inflation tube detached and/or tore from the main t... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 19, 2024 | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 19, 2024 | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 14, 2024 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30... | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... | Class II | Covidien, LP |
| Feb 14, 2024 | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... | Class II | Covidien, LP |
| Jan 30, 2024 | Epix Universal Clip Applier, REF: CA500, STERILEEO included within the follow... | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. | Class II | Applied Medical Resources Corp |
| 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 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 | 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 3, 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... | Due to software and controller systems that results in unexpected pump start or pump stop. | Class I | Thoratec Corp. |
| Dec 15, 2023 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model... | Devices may not be rendered sterile due to an internal gap that may be present on some devices ca... | Class II | Globus Medical, Inc. |
| Dec 12, 2023 | Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 | Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... | Class II | Steris Corporation |
| Dec 12, 2023 | Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 | Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... | Class II | Steris Corporation |
| Dec 1, 2023 | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... | Class II | Maquet Cardiovascular, LLC |
| Dec 1, 2023 | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... | Class II | Maquet Cardiovascular, LLC |
| Nov 28, 2023 | Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... | Class II | AtriCure, Inc. |
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.