Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
Oct 30, 2018 Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A... Potential for chemical analyzer to report abnormal results due to an interference with triglyce... Class II Horiba Instruments Incorporated
Oct 30, 2018 Porcine Anorganic Bone Mineral 4.0cc There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume an... Class III Collagen Matrix Inc
Oct 26, 2018 Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family ... This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-r... Class II Siemens Medical Solutions USA, Inc
Oct 26, 2018 Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX ... Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling... Class II Merit Medical Systems, Inc.
Oct 26, 2018 Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, R... Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling... Class II Merit Medical Systems, Inc.
Oct 26, 2018 Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, ... packaging error; An internal QA inspection revealed that a incorrect healing collar could have ... Class II Implant Direct Sybron Manufacturing, LLC
Oct 25, 2018 QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000... There is a potential for blood leakage at the blood inlet connector when using the reducing screw... Class I Maquet Cardiovascular Us Sales, Llc
Oct 25, 2018 HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balanc... Class II The Magstim Company Limited
Oct 25, 2018 QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10... There is a potential for blood leakage at the blood inlet connector when using the reducing screw... Class I Maquet Cardiovascular Us Sales, Llc
Oct 25, 2018 da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch The instrument drape may tear while draping the Patient Side Cart presenting a breach in the ster... Class II Intuitive Surgical, Inc.
Oct 24, 2018 Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inser... Potential metal burrs in the holes of the device preventing the appropriate drill and transverse... Class II Zimmer Biomet, Inc.
Oct 24, 2018 NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoM... The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date... Class III Neomed Inc
Oct 23, 2018 The da Vinci SP surgical system is made of three main components: the Surgeon... The firm became aware of a problem with the surgical system where the cannula mount button may be... Class II Intuitive Surgical, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Di... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-S... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
Oct 22, 2018 Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Le... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT ... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
Oct 22, 2018 PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flo... It is possible that the packaging of the product can be damaged by the prongs on the tube set. Class II WOM World of Medicine AG
Oct 22, 2018 Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Num... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diam... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these... False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were r... Class II bioMerieux, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Le... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-sele... a portion of a single lot was not manufactured in accordance with the internal formulation result... Class II Becton Dickinson & Co.
Oct 22, 2018 Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108 Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The ... Inspection process at the manufacturer found nonwoven material was used in specific lots of produ... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item N... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm ... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 19, 2018 VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vi... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vit... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system... Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co... Class II Siemens Medical Solutions USA, Inc
Oct 19, 2018 VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in th... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system ... Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co... Class II Siemens Medical Solutions USA, Inc
Oct 19, 2018 VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vit... Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class II Ortho-Clinical Diagnostics
Oct 19, 2018 ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Pro... Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co... Class II Siemens Medical Solutions USA, Inc
Oct 18, 2018 HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Cat... Incorrect measurement results caused by microbial contamination of the product, results in values... Class II EUROTROL INC
Oct 18, 2018 Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomograph... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomograph... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray sys... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomogra... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray syst... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography... There is a potential for separation of fiberglass resin which may cause the gantry front cover an... Class II Philips Medical Systems (Cleveland) Inc
Oct 18, 2018 HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Ca... Incorrect measurement results caused by microbial contamination of the product, results in values... Class II EUROTROL 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.