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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

1,677 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,677 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 1,677 FDA device recalls in MN.

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DateProductReasonClassFirm
Dec 10, 2015 Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices ... The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it... Class II Boston Scientific Corporation
Dec 10, 2015 Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices t... The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it... Class II Boston Scientific Corporation
Dec 3, 2015 Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3... There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Al... Class II Smiths Medical ASD Inc.
Dec 1, 2015 QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets... The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164... Class II Microbiologics Inc
Dec 1, 2015 QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets ... The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164... Class II Microbiologics Inc
Dec 1, 2015 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M... Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. Thi... Class II 3M Company - Health Care Business
Nov 25, 2015 Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104... Potential for separation of the proximal handle from the shaft. Class II Boston Scientific Corporation
Nov 19, 2015 Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene o... Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientifi... Class I Boston Scientific Corporation
Nov 13, 2015 Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Steril... Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed ca... Class II STERILMED, INC.
Nov 9, 2015 Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generat... Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term batte... Class II Medtronic Inc.
Oct 28, 2015 Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Ste... This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactu... Class II Medtronic Perfusion Systems
Oct 26, 2015 MiniArc Pro Single incision Sling System, Model number / Product Reference 90... The lot number on the outer carton label did not match the lot number printed on the tray label o... Class II Astora
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Sep 29, 2015 Medtronic Achieve Cables, model 990066. The sterile, single use only Electri... 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. Class II Medtronic Inc.
Sep 17, 2015 Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). ... Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communi... Class II Boston Scientific Corporation
Sep 16, 2015 BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartrid... May report values outside the published performance specifications for pH. After a certain point... Class II LifeHealth, LLC
Sep 16, 2015 CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartri... May report values outside the published performance specifications for pH. After a certain point... Class II LifeHealth, LLC
Sep 15, 2015 Medtronic Medical Device Identification Card for SureScan pacemaker patients.... Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they ha... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Sep 14, 2015 PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF... The label on the lid stock of the individual needle packages for a portion of Lot number 46262 co... Class II Smiths Medical ASD, Inc.
Sep 3, 2015 AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm... Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog #... Class II Summit Medical, Inc.
Sep 1, 2015 Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performin... An issue with a USB memory component contained within a subset of CryoConsoles can result in exte... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Aug 25, 2015 Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F S... Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... Class II Boston Scientific Corporation
Aug 25, 2015 Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Deliver... Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... Class II Boston Scientific Corporation
Aug 24, 2015 Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Br... Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot nu... Class II STERILMED, INC.
Aug 18, 2015 MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist ... Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... Class II Medtronic Perfusion Systems
Aug 18, 2015 Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-10... The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the ... Class II Ecolab Inc
Aug 18, 2015 MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators... Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... Class II Medtronic Perfusion Systems
Aug 6, 2015 Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile... Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) ... Class II Tornier, Inc
Aug 3, 2015 Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene o... Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. Class II Medivators, Inc.
Jul 31, 2015 AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized ... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog N... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, S... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 24, 2015 Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to... EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. Class II Medtronic Perfusion Systems
Jul 17, 2015 LYFO Disk LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Cat... Class III Microbiologics Inc
Jun 25, 2015 Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic man... Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports ... Class II Tornier, Inc
Jun 16, 2015 Celsite Implantable Access Port System, model ST301. The Celsite Implantable... The manufacturer, B. Braun medical France, received endotoxin test results that are out of specif... Class II B. Braun Interventional Systems
Jun 15, 2015 Block Versions Used by Dental Offices often referred to as chairside milling:... 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate produc... Class II 3M Company - Health Care Business
Jun 12, 2015 Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and D... Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports ... Class II Medtronic Perfusion Systems
May 26, 2015 CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Versio... Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the loc... Class II Smiths Medical ASD, Inc.
May 2, 2015 Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch du... Class I Synovis Surgical Innovations, Inc.
Apr 29, 2015 LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care setti... The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will... Class II LifeHealth, LLC
Apr 16, 2015 Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 370... Medtronic is providing Important information regarding extension handling during implant procedur... Class II Medtronic Neuromodulation
Apr 10, 2015 Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-4... Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II ... Class II Medtronic Neuromodulation
Apr 9, 2015 Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/5... Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box an... Class II Coloplast Manufacturing US, LLC
Mar 23, 2015 Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Periphe... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 21, 2015 Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in... Class II Smiths Medical ASD, Inc.
Mar 19, 2015 Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable... A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-... Class II Incisive Surgical Inc
Mar 17, 2015 Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product... Possible performance issue when used with specific AA-sized (LR6) batteries. The negative termina... Class II Medtronic Inc. Cardiac Rhythm Disease Management

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.