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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

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Aug 23, 2016 Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, ... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packag... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 17, 2016 Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: ... Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potentia... Class II Stryker Instruments Div. of Stryker Corporation
Aug 5, 2016 Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile... Polypropylene Surgical Sutures are recalled because the seals may become open during distribution... Class II Riverpoint Medical, LLC
Aug 5, 2016 Nylon Surgical Suture for human use and vet use, sold under brand name Riverl... Nylon Surgical Sutures are recalled because the seals may become open during distribution or subs... Class II Riverpoint Medical, LLC
Aug 2, 2016 Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner ca... Certain lots of the acid solution in Acecide-C are degrading faster than normal. Class II Best Sanitizers Inc
Jul 26, 2016 Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two s... The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone c... Class II Encore Medical, Lp
Jul 19, 2016 Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used ... Sterility compromised due to breach in sterile packaging Class II Smith & Nephew, Inc.
Jul 15, 2016 Affinity Four Birthing Bed Model P3700 The primary packaging is pictured... Class II Hill-Rom, Inc.
Jul 14, 2016 Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Mi... Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile pac... Class II Ecolab Inc
Jul 13, 2016 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usa... A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/pa... Class II AccessClosure, Inc., A Cardinal Health Company
Jul 5, 2016 AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The Amed... Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may e... Class III Branan Medical Corporation
Jun 30, 2016 Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint meta... Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging o... Class II Zimmer Gmbh
Jun 27, 2016 CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual ... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Ca... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 27, 2016 CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... The packaging seal may contain a crease. The crease may result in an open channel. These channel... Class II ConMed Corporation
Jun 22, 2016 Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 15, 2016 Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209... The device could be subject to breaches of its sterile packaging. Class II Smith & Nephew, Inc.
May 27, 2016 Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring de... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring de... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For color... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For colori... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For colori... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For colo... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For colorin... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring d... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For c... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 13, 2016 MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK... It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK She... Class II Datascope Corporation

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.