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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

Infrastructure

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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Medical Device Recalls

Search 39,539 FDA medical device recalls and enforcement actions. Check if devices you use have been recalled for safety reasons.

Browse All Recalls By Classification
0Total Recalls
0Class I Recalls
0Class II Recalls
0Years of Data

Search Recalls

Find FDA medical device recalls by device name, reason, or manufacturer. Covers all enforcement actions since 1930.

Browse by Year

View device recalls by year to see trends in medical device safety enforcement.

Latest Device Recalls

Most recently initiated FDA medical device safety recalls.

DateProductReasonClassFirm
Jun 16, 2026 Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... Class II Accuray Incorporated
Jun 16, 2026 Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... Class II Accuray Incorporated
Jun 9, 2026 Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console ... Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersec... Class II CMR SURGICAL LIMITED
Jun 9, 2026 Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... Class II Zimmer Surgical Inc
Jun 9, 2026 Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... Class II Zimmer Surgical Inc
Jun 8, 2026 Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atelli... Class II Siemens Healthcare Diagnostics, Inc.
Jun 8, 2026 KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, A product error defect may cause incorrect bracket placement. Class II Klowen Braces
Jun 8, 2026 Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R Surgical dressing manufactured out of specification (greater thickness). Class II ConvaTec, Inc
Jun 8, 2026 ARTIS icono ceiling. Model Number: 11328100. Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place.... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2026 OmniTract Surgical Retractor System, which includes 633 of the firm s product... The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra Lif... Class II Integra LifeSciences Corp. (NeuroSciences)
View All Device Recalls

Recalls by Year

FDA medical device recalls initiated per year.

YearRecalls
20261,279
20252,834
20243,276
20232,609
20222,276
20212,260
YearRecalls
20202,602
20193,010
20183,013
20173,313
20163,029
20152,907
YearRecalls
20142,729
20132,437
20121,550
2011210
201065
200993
YearRecalls
200819
200712
200612
20053
19301

Top Recalling Firms

Companies with the most FDA device recall actions.

#FirmRecalls
1Zimmer Biomet, Inc.875
2MEDLINE INDUSTRIES, LP - Northfield812
3Customed, Inc682
4Siemens Medical Solutions USA, Inc623
5Boston Scientific Corporation619
6ICU Medical, Inc.594
7GE Healthcare, LLC474
8Medline Industries, LP460
9Siemens Healthcare Diagnostics, Inc.456
10Zimmer, Inc.444
11Arrow International Inc431
12Olympus Corporation of the Americas408
13Baxter Healthcare Corporation375
14Biomerieux Inc369
15Covidien LLC334

How It Works

1

Search Device Recalls

Enter a device name, type, or manufacturer. Our database covers every FDA medical device enforcement action from 1930 to 2026.

2

Review the Details

See the full recall information including classification level, reason for recall, recalling firm, and whether the device poses serious health risks.

3

Take Action

If you have a recalled medical device, contact your healthcare provider immediately. Do not attempt to modify or repair the device yourself. Follow the manufacturer's instructions for return or replacement.

Frequently Asked Questions

An FDA medical device recall is an action taken to address a problem with a medical device that violates FDA law. A recall may be initiated by the manufacturer, importer, or FDA itself. Recalls address issues such as software errors, manufacturing defects, labeling problems, sterility failures, and component malfunctions. Medical devices range from simple bandages to complex implantable devices like pacemakers and artificial joints.

Class I is the most serious, there is a reasonable probability that use of the device will cause serious adverse health consequences or death. Class II means the device may cause temporary or medically reversible adverse health effects. Class III is the least serious, unlikely to cause adverse health consequences.

Contact your healthcare provider immediately, especially for implanted devices. Do not remove or modify any implanted device yourself. Follow the recall instructions for returning or replacing the device. Your doctor can determine whether immediate action is needed or if monitoring is sufficient. Report any adverse events to the FDA through MedWatch.

All medical device recall data comes from the U.S. FDA through the openFDA enforcement database. We maintain 39,539 device safety records from 1930 to 2026.