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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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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 22, 2025 OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical ... The potential for unsterilized product within finished product labeled as sterile. Class II LUMENIS, LTD.
Jan 23, 2025 (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pul... The initial current in certain chargers may lead to overheating and damage to the power resistors... Class II LUMENIS, LTD.
Jan 15, 2024 Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) When using those products you may experience difficulties to extend or retract the laser fiber, a... Class II D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Jan 15, 2024 Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) When using those products you may experience difficulties to extend or retract the laser fiber, a... Class II D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Jan 15, 2024 Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) When using those products you may experience difficulties to extend or retract the laser fiber, a... Class II D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Oct 14, 2021 IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Lumenis, Inc.
Sep 25, 2016 FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch"... The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a full... Class II Lumenis Limited
Nov 17, 2015 Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne ... Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Pie... Class II Lumenis Ltd
Jul 30, 2015 Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / Ver... There is a probability the hand piece may operate inconsistently and unpredictably during the mor... Class II Lumenis
Mar 25, 2015 Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Device software treatment preset parameters for the XC treatment handpiece do not match the Opera... Class II Lumenis Limited
Aug 15, 2014 Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser... Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) becau... Class II Lumenis, Inc.
Aug 19, 2013 Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. ... Lumenis has initiated a recall on certain models of Vision One System due to a potential for unin... Class II Lumenis, Inc.
Jan 2, 2013 The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for ... Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective lab... Class I Lumenis Limited

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.