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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

3,096 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,096 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 3,096 FDA device recalls.

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DateProductReasonClassFirm
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... Class II Nephron Pharmaceuticals Corp.
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.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. In... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STE... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Pl... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Gu... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking br... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indi... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
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 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 9, 2015 Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical... B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage ... Class II Intuitive Surgical, Inc.
Aug 27, 2015 Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the ... Class II Arrow International Inc
Aug 25, 2015 Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical k... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for car... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular s... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 19, 2015 Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. U... Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... Class II Resource Optimization & Innovation Llc
Aug 19, 2015 Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG ... Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... Class II Resource Optimization & Innovation Llc
Aug 6, 2015 Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with I... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Strai... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Cur... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safet... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curve... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Produ... Sterility may be compromised Class II Covidien 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.