Browse Device Recalls

1,646 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,646 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 1,646 FDA device recalls in MN.

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DateProductReasonClassFirm
Mar 19, 2024 Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Clearview Blower/Mister, Model Number 22120 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip,... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Mode... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt,... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Mode... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 11, 2024 Ureteral dilator, REF RBD014 A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facil... Class II Coloplast Manufacturing US, LLC
Mar 6, 2024 KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b... The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminate... Class II Microbiologics Inc
Mar 5, 2024 DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device use... Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Int... Class II Beckman Coulter, Inc.
Mar 5, 2024 OptiCross Coronary Imaging Catheter, REF H749518080120 Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect vo... Class II Boston Scientific Corporation
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 27, 2024 CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the foll... The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... Class I Smiths Medical ASD Inc.
Feb 27, 2024 CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following ... CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following ... Class I Smiths Medical ASD Inc.
Feb 27, 2024 CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, a... The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... Class I Smiths Medical ASD Inc.
Feb 26, 2024 NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, t... Class II Navinetics Inc
Feb 20, 2024 Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilit... Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Int... Class II Boston Scientific Corporation
Feb 20, 2024 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; ... Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top fil... Class II 3M Company - Health Care Business
Feb 20, 2024 Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0... An investigation determined that delivery of the Obsidio embolic using the aliquot technique for ... Class I Boston Scientific Corporation
Feb 16, 2024 Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090;... There is a potential for sterile package breach. Class II Medtronic Inc.
Feb 15, 2024 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... Class II Augustine Temperature Management, LLC
Feb 15, 2024 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... Class II Augustine Temperature Management, LLC
Feb 12, 2024 Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 Boston Scientific has identified a tooling error in manufacturing which may have caused delaminat... Class I Boston Scientific Corporation
Feb 8, 2024 Access Total T4, REF 33800, IVD, thyroxine reagent assay. Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specificati... Class II Beckman Coulter, Inc.
Feb 7, 2024 Access Substrate, REF 81906, For use with the Access Immunoassay Systems On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... Class II Beckman Coulter, Inc.
Feb 7, 2024 smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP,... When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... Class I Smiths Medical ASD Inc.
Feb 7, 2024 Medtronic DLP Vessel Cannula, Model Number REF 30000 Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... Class II Medtronic Perfusion Systems
Feb 7, 2024 smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, RE... When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... Class I Smiths Medical ASD Inc.
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 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 8, 2024 Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. The negative control was contaminated with one of the positive control pathogens (Norovirus). Th... Class II Microbiologics Inc
Jan 3, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; ... A software error caused an increase in tray gripper motion errors that causes intermittent hard s... Class II Beckman Coulter, Inc.
Jan 3, 2024 Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DW... The incorrect device is contained in the labeled package. Class II Tornier, Inc
Dec 19, 2023 Model A710 Intellis Clinician Programmer Application, version 2.0.97 Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application ... Class II Medtronic Neuromodulation
Dec 19, 2023 Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medf... Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 ... Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 smiths medical Medfusion Model 4000 syringe pump Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f... Class I Smiths Medical ASD Inc.
Dec 19, 2023 Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-01... Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... Class II Smiths Medical ASD Inc.
Dec 19, 2023 smiths medical Medfusion Model 3500 Syringe pump Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. D... Class I Smiths Medical ASD Inc.
Dec 18, 2023 TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F ... When the catheters are used with the EnSiteX EP System, the system does not correctly recognize t... Class II St. Jude Medical, Atrial Fibrillation Division,...
Dec 13, 2023 DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 13... Class II Diasorin Inc.
Dec 7, 2023 Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product num... During internal review of Polaris battery assembly data from the HiPot operation, a test systems ... Class II Medtronic Inc.
Nov 30, 2023 Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ... The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generator... Class II Boston Scientific Corporation
Nov 21, 2023 DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, includi... Class II Beckman Coulter, Inc.
Nov 21, 2023 Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay An... There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with t... Class II Beckman Coulter, 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.