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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: ... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE... A software issue related to the generic volume measurement functionality could result in the volu... Class II Carestream Health Inc
Jul 8, 2016 Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E2583... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the air powered Bone drill (V... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi Inc.
Jul 8, 2016 Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 T... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 ... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Va... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code:... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 Th... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E27... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Va... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi Inc.
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E25... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R3... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The V... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the air powered dental handpi... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi Inc.
Jul 8, 2016 Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The V... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The V... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Ite... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The V... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: ... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Medical Linear Accelerator There have been instances in hospitals where the joint between the drive gear and the gantry base... Class II Elekta, Inc.
Jul 7, 2016 T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-0... Elevated levels of invalid results. Class II T2 Biosystems Inc
Jul 7, 2016 Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to ... Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This state... Class II TZ Medical, Inc.
Jul 7, 2016 The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF devi... This field action is being initiated following the firm's discovery of a procedural error in the ... Class III Zimmer Trabecular Metal Technology, Inc.
Jul 7, 2016 Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10... Increase in the failure rate of certain low-voltage DC power supplies (DCPS) Class II Philips Electronics North America Corporation
Jul 7, 2016 Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Mo... Due to an error in the 19 Live Display, image reproduction may fail in the examination room and ... Class II Siemens Medical Solutions USA, Inc
Jul 7, 2016 UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD... Increase in the failure rate of certain low-voltage DC power supplies (DCPS) Class II Philips Electronics North America Corporation
Jul 7, 2016 Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is ... Arrow is recalling due to incorrect labeling of products. Class II Arrow International Inc
Jul 6, 2016 Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number... May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. Class II Bard Peripheral Vascular Inc
Jul 6, 2016 EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended ... The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. Class II Dako Denmark A/S
Jul 6, 2016 SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1),... The labels correctly state that the product should be a 25mm screw, but the box contained a longe... Class II Smith & Nephew, Inc.
Jul 5, 2016 Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software ... Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the ... Class III Siemens Healthcare Diagnostics Inc
Jul 5, 2016 RePlant¿ Angled Abutment Part Number 6050-52-60 Issue with design specification; oversized condition. Class II Implant Direct Sybron Manufacturing, LLC
Jul 5, 2016 Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Pr... Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 3... Class II The Binding Site Group, Ltd.
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
Jul 4, 2016 Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device... Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . ... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width pla... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimme... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width pla... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Wid... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. T... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate i... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 1, 2016 Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain pl... There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) resu... Class II Sysmex America Inc
Jul 1, 2016 RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.... An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation... Class II RAYSEARCH LABORATORIES AB

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.