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
Nov 20, 2023 Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-... Seal defects could compromise the ability of the product packaging to maintain sterility. Class II Medtronic Inc.
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-40, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-20, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 3, 2023 ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor It may create the potential for amplified noise and/or overall signal reduction of the ICM, which... Class II Medtronic Inc.
Oct 19, 2023 Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimula... Units distributed in Korea and Turkey that did not have the correct firmware installed to support... Class II Medtronic Neuromodulation
Oct 18, 2023 LYFO-DISK, P. venetum, Catalog number 0794L A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... Class II Microbiologics Inc
Oct 18, 2023 KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... Class II Microbiologics Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... Class II Medtronic Inc
Sep 28, 2023 Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning gen... Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out o... Class II Abbott
Sep 15, 2023 stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25m... One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured ... Class II Tornier, Inc
Sep 12, 2023 DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and b... The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information... Class II Beckman Coulter, Inc.
Sep 6, 2023 Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the pa... Class II Smiths Medical ASD Inc.
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qu... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designe... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P... The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) b... Class II Smiths Medical ASD Inc.
Aug 22, 2023 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualif... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 16, 2023 Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on... A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) ... A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0... A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 16, 2023 Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... Class II Smiths Medical ASD Inc.
Aug 14, 2023 KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides ... Class III Microbiologics Inc
Jul 27, 2023 Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M00310142... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M00310143... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M00310146... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M00310162... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M00310144... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M00310148... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M00310147... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M00310163... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 18, 2023 PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflectin... Class II Smiths Medical ASD Inc.
Jul 11, 2023 EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardiov... There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... Class II Boston Scientific Corporation
Jul 11, 2023 EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverte... There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... Class II Boston Scientific Corporation
Jul 6, 2023 Access Thyroglobulin Calibrators It has been determined through an internal investigation that the alternate Access Thyroglobulin ... Class II Beckman Coulter, Inc.
Jul 6, 2023 Medtronic InterStim Ground Pad REF 041826 Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with... Class II Medtronic Neuromodulation
Jun 23, 2023 Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecol... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Jun 23, 2023 Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Jun 21, 2023 A901 Communication Manager Application, used in conjunction with the A710 Cli... When an update to the A710 Clinician Programmer software application for the Intellis Neurostimul... Class II Medtronic Neuromodulation

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.