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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 11, 2018 Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port a... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: ... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Shea... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Cathet... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Maximal Barrier Drape; Product Code: ASK-04000-HMC Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, ... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM,... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM,... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, ... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Leng... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Leng... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm ... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, ... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis... Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. Class II Tornier, Inc
Mar 26, 2018 Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-225... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 21, 2018 Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Pro... Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iod... Class II Bard Medical Division
Mar 15, 2018 Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655... These products contain latex, but the following statement is not included on any level of product... Class II Teleflex Medical Europe Ltd
Mar 15, 2018 Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 ... These products contain latex, but the following statement is not included on any level of product... Class II Teleflex Medical Europe Ltd
Mar 15, 2018 Rectal Catheters; Product Code Equivalent Code 580114 580114 ... These products contain latex, but the following statement is not included on any level of product... Class II Teleflex Medical Europe Ltd
Mar 15, 2018 Simplastic Suprapubic Puncture Instruments: Product Code Equivalent... These products contain latex, but the following statement is not included on any level of product... Class II Teleflex Medical Europe Ltd
Mar 12, 2018 Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of ... The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labe... Class II Stryker GmbH
Feb 21, 2018 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable ... The secondary packaging is labeled with an incorrect expiration date. Class III CooperVision Inc.
Feb 21, 2018 clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, da... The secondary packaging is labeled with an incorrect expiration date. Class III CooperVision Inc.
Feb 21, 2018 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable ... The secondary packaging is labeled with an incorrect expiration date. Class III CooperVision Inc.
Feb 21, 2018 clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily dispo... The secondary packaging is labeled with an incorrect expiration date. Class III CooperVision Inc.
Feb 2, 2018 Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... This recall has been identified due to the batch being mislabeled, with the packaged component's... Class II Signature Orthopedics Pty Limited
Jan 25, 2018 CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based ... The recalled products were shipped without the required temperature control packaging, therefore ... Class II Stryker Corporation
Jan 3, 2018 HEMASHIELD Knitted Double Velour Cardiovascular Fabric A probable mislabeling of the product: a different-sized product is referenced on the product pac... Class II GETINGE US SALES LLC
Dec 20, 2017 Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, ... Medtronic is initiating a voluntary recall because the products identified above did not adequate... Class II Medtronic Neurosurgery
Dec 11, 2017 Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek ... Class II Smith & Nephew, Inc.
Nov 29, 2017 VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160M... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMOR... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polyme... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polyme... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FE... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP S... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-K... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, Inc.
Nov 29, 2017 VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT... The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... Class II Zimmer Biomet, 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.