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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

3,306 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,306 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 3,306 FDA device recalls in IL.

Clear
DateProductReasonClassFirm
Nov 30, 2015 Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 30, 2015 Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, ... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 27, 2015 Bond Polymer Refine Red Detection DS9390 kits. The common name of the device ... The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred d... Class II Leica Microsystems, Inc.
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751514. The oval burr fron... Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the dist... Class II Richard Wolf Medical Instruments Corp.
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751504. The oval burr late... Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the dist... Class II Richard Wolf Medical Instruments Corp.
Nov 25, 2015 Reuseable rotary blade/abrader, product number 899751305. The round burr is... Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the dist... Class II Richard Wolf Medical Instruments Corp.
Nov 20, 2015 WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of stea... "The public reason for the recall is that the product is being recalled out of an abundance of ca... Class II Bigwall Enterprises
Oct 6, 2015 Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path Leakage from the inlet port of the 15L Cycler Drainage Bags. Class II Baxter Healthcare Corp.
Sep 28, 2015 The Centricity PACS-IW with Universal Viewer is a device that displays medica... Inaccurate distance measurements with magnified projection X-ray images. Class II GE Healthcare
Sep 28, 2015 The Centricity Universal Viewer Version is a device that displays medical ima... Inaccurate distance measurements with magnified projection X-ray images. Class II GE Healthcare
Sep 16, 2015 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... Images may be missing when a system parameter MapRoute is set to a value greater than 1. Class II GE Healthcare
Sep 3, 2015 Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochem... These Lot numbers are not stable up to the expiry date on the product labeling. Class II Leica Microsystems, Inc.
Aug 25, 2015 Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal... Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commer... Class II Cardinal Health
Aug 11, 2015 Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PA... Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... Class II GE Healthcare
Aug 11, 2015 Centricity Universal Viewer Product Usage: The Centricity Universal Viewe... Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... Class II GE Healthcare
Aug 5, 2015 The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departme... The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm ... Class III Leica Microsystems, Inc.
Aug 3, 2015 Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Wee... The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying ... Class II Medline Industries Inc
Jul 31, 2015 Siemens Symbia T Series, a radiological imaging system that is a combination ... Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... Class II Siemens Medical Solutions USA, Inc.
Jul 31, 2015 Siemens Intevo Series system, a radiological imaging system that is a combina... Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... Class II Siemens Medical Solutions USA, Inc.
Jul 31, 2015 Siemens Symbia S Series system, a diagnostic analog or digital detector based... Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi... Class II Siemens Medical Solutions USA, Inc.
Jul 27, 2015 The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. ... The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty du... Class II Leica Microsystems, Inc.
Jul 8, 2015 Medline Electrical Clipper with Charging base The Electrical Surgical Cli... Charging base of surgical clippers overheats and smokes. Class II Medline Industries Inc
Jun 29, 2015 Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automat... Loud operating sounds, which was unacceptable to the end users when the device was powered on. Th... Class III Baxter Healthcare Corp.
Jun 26, 2015 e.cam Gamma Camera, an emission computed tomography system. It is intended to... Potential failure mode related to the radial brake, where the detector was able to drift, led to ... Class II Siemens Medical Solutions USA, Inc.
Jun 11, 2015 ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARC... The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the pote... Class II Abbott Laboratories
May 21, 2015 ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONN... Potential for a leak at the tubing to luer bond. Class II Baxter Healthcare Corp
May 11, 2015 Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Ar... The product is leaking from the cap and crystallization was noted as present around the cap. Class II Abbott Laboratories
Apr 17, 2015 GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthope... Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws inst... Class II Medacta Usa
Mar 23, 2015 Sedecal SA Mobile Diagnost w DR x-ray system Due to a software defect, the system may sporadically apply the default x ray exposure parameters... Class II Sedecal USA, Inc.
Mar 2, 2015 Master Drug Library Software version 8.0, Product Code 35723V080, to be used ... Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump d... Class II Baxter Healthcare Corp
Feb 12, 2015 Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouche... Devices were not sterilized Class II Ameda, Inc.
Feb 12, 2015 Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primar... Devices were not sterilized Class II Ameda, Inc.
Jan 22, 2015 MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. Product may have separating or protruding sponges Class II Baxter Healthcare Corp.
Jan 14, 2015 Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Pla... Potential for failure of the pouch packaging seal at high altitudes. Class II Baxter Healthcare Corp.
Dec 23, 2014 Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube t... A small piece of the stylet sheath has the potential to shear off upon removal of the stylet fro... Class II Cardinal Health
Dec 19, 2014 HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 US... The lot failed pH specification. Class II Fresenius Kabi USA, LLC
Dec 18, 2014 Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophtha... The devices were not shipped with the Starter Kits. Class II Ziemer Usa Inc
Dec 16, 2014 Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunoh... The staining intensity decreases over the shelf life. Class II Leica Microsystems, Inc.
Dec 10, 2014 The I-Cart is used to store, transport, and power video equipment used in med... The transformers installed on carts used for Richard Wolf medical video systems may overheat caus... Class II Richard Wolf Medical Instruments Corp.
Dec 8, 2014 Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid ... Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Casse... Class II Baxter Healthcare Corp.
Nov 29, 2014 Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification ... Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... Class I Vyaire Medical
Nov 29, 2014 Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with Ai... Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... Class I Vyaire Medical
Nov 29, 2014 Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing ... Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... Class I Vyaire Medical
Nov 29, 2014 Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidif... Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... Class I Vyaire Medical
Oct 28, 2014 The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position ... The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the... Class II Summit Industries Inc.
Oct 23, 2014 Abbott m2000sp, an automated system for performing sample preparation for nuc... Some versions of Application Specifications (App Spec) are incompatible with m2000sp system softw... Class II Abbott Molecular
Oct 21, 2014 HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal... The keypad buttons on HomeChoice devices may be activated without the operator pressing them. Class II Baxter Healthcare Corp.
Oct 21, 2014 The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert th... The MectaLIF Oblique Handle has the laser marking &quot;MEDIAL&quot; on the incorrect side and co... Class II Medacta Usa
Oct 6, 2014 HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter'... There are additional and updated warning and cautions that are not in the Patient At-Home Guide f... Class II Baxter Healthcare Corp.
Sep 22, 2014 GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignm... Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension R... Class II Medacta Usa

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.