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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

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

Clear
DateProductReasonClassFirm
May 23, 2016 PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy Presence of leaks near top of the PrismaSate bags Class II Baxter Healthcare Corp.
May 19, 2016 Conical portio adapter (acorn) small & large are used for examination and dia... The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that parti... Class II Richard Wolf Medical Instruments Corp.
May 11, 2016 Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of... There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup... Class II Medline Industries Inc
May 6, 2016 Ariol is an automated scanning microscope and image analysis system. It is in... An issue during the manufacturing process caused systems to have an improperly activated Windows ... Class III Leica Biosystems Richmond Inc.
May 2, 2016 CytoVision Image Analysis and Capture System, an automated cell-locating devi... Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was asso... Class III Leica Biosystems Richmond Inc.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 5, 2016 Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) ... Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up ... Class II Leica Microsystems, Inc.
Apr 5, 2016 Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the... Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the e... Class II Leica Microsystems, Inc.
Mar 31, 2016 E.cam or Symbia systems that use foresight detectors - Product Usage: To dete... E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may los... Class II Siemens Medical Solutions USA, Inc.
Mar 25, 2016 The Plum 360 is a large volume infuser capable of delivering fluids for a var... Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att... Class II Hospira Inc.
Mar 25, 2016 The Plum A+ is a dual-line volumetric infusion system designed to meet the gr... Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att... Class II Hospira Inc.
Mar 24, 2016 The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic ... Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estrad... Class II Abbott Laboratories
Mar 22, 2016 Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. ... Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lot... Class II Leica Microsystems, Inc.
Feb 29, 2016 Gomco Style Circumcision Clamp Trays is an instrument used to compress the fo... Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumci... Class II Cardinal Health
Feb 29, 2016 The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera... Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts a... Class II Richard Wolf Medical Instruments Corp.
Feb 26, 2016 The E.CAM gamma camera system Product Usage: The E.CAM gamma camera syst... We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-000... Class II Siemens Medical Solutions USA, Inc.
Feb 26, 2016 The Symbia gamma camera system Product Usage: The Symbia gamma camera sy... We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-000... Class II Siemens Medical Solutions USA, Inc.
Feb 18, 2016 The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Ov... The instructional insert for the In Touch Control Solution for use with the In Touch meter and I... Class II Livongo Health
Feb 16, 2016 Automated peritoneal dialysis (APD) cycler Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructi... Class II Baxter Healthcare Corp.
Jan 11, 2016 Leica Microsystems (Schweiz) Ag. The common name of the device is surgical mi... An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W i... Class II Leica Microsystems, Inc.
Dec 31, 2015 The e.cam Dual Signature Gamma Camera system. Used to detect or image the di... To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not ... Class II Siemens Medical Solutions USA, Inc.
Dec 30, 2015 This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody ... The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequat... Class II Leica Microsystems, Inc.
Dec 22, 2015 The Symbiq infusion pump is a device used in a health care facility to pump f... Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad. Class II Hospira Inc.
Dec 21, 2015 The Concerto Basic Shower Trolley is intended for assisted hygiene care, espe... Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting m... Class II Arjo, Inc. dba ArjoHuntleigh
Dec 3, 2015 VS300 radiographic Cassette Holder or Wall Stand. For use in radiology depart... The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and... Class II Del Medical, Inc.
Dec 3, 2015 VS200 radiographic Cassette Holder or Wall Stand. For use in radiology depart... The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and... Class II Del Medical, Inc.
Nov 30, 2015 Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: F... 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 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.

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.