Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 23, 2024 | Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Cata... | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3... | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. | Some applicator tips from these lots had open seals. | Class II | Ethicon, Inc. |
| Apr 23, 2024 | Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2... | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | DAC 044 115cm, Catalog: 90760 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wi... | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or with... | Quarantined product was inadvertently distributed | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 23, 2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | There is the potential that an electroneurodiagnostic medical device insulator may be installed i... | Class II | Cadwell Industries Inc |
| Apr 23, 2024 | Trevo Trak 21 Microcatheter, Catalog: 90338 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | Trevo ProVue, Catalog: 90184 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 22, 2024 | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including ... | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital s... | Class II | Murata Vios, Inc. |
| Apr 22, 2024 | Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology... | Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resul... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 22, 2024 | ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 806592... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: ... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended t... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 22, 2024 | Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondVi... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010 | It has been identified that testing documentation does not support that the syringes can successf... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform ... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Up... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 22, 2024 | Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems ... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 22, 2024 | ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Ar... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-2... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 | It has been identified that testing documentation does not support that the syringes can successf... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2024 | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems ar... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 19, 2024 | Patient Information Center iX and Patient Information Center iX Expand, Softw... | Event Catalog information does not save when copied and transferred from one unit to another. | Class II | Philips North America Llc |
| Apr 18, 2024 | OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-2... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26M... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OES 4000 Hysteroscope, Model/Catalog Number: A4674A | The required leakage test was not performed following of a re-work for a non-conformity. This cou... | Class II | Olympus Corporation of the Americas |
| Apr 18, 2024 | Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitr... | When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is co... | Class II | Beckman Coulter, Inc. |
| Apr 18, 2024 | Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R... | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system chec... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 18, 2024 | Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545,... | A small number of devices may have a higher probability of a crack within the internal electronic... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Apr 18, 2024 | The Synchro Neuro Guidewires are a steerable guidewire family with a shapeabl... | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... | Class II | Stryker Neurovascular |
| Apr 18, 2024 | The Synchro SELECT Guidewires are a steerable guidewire family with a shapeab... | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... | Class II | Stryker Neurovascular |
| Apr 18, 2024 | DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic | Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic ... | Class II | Beckman Coulter, Inc. |
| Apr 18, 2024 | OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump | Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the... | Class I | OptumHealth Care Solutions LLC |
| Apr 18, 2024 | Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 Sma... | Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing del... | Class II | BD SWITZERLAND SARL |
| Apr 18, 2024 | The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip... | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the... | Class II | Stryker Neurovascular |
| Apr 17, 2024 | Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S ... | Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ... | Class II | YAMAHA MOTOR CORPORATION |
| Apr 17, 2024 | Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YS... | Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ... | Class II | YAMAHA MOTOR CORPORATION |
| Apr 17, 2024 | Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881,... | These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. L... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9... | Potential contamination of the product with latex adhesive residual. | Class II | 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.