Browse Device Recalls

3,367 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,367 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 3,367 FDA device recalls in IL.

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DateProductReasonClassFirm
Feb 12, 2014 ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibra... Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential... Class II Abbott Laboratories
Feb 7, 2014 SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... Class I Baxter Healthcare Corp.
Feb 3, 2014 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... Class I Hospira Inc.
Feb 3, 2014 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... Class I Hospira Inc.
Jan 31, 2014 GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (... The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump wi... Class II Hospira Inc.
Jan 24, 2014 LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusi... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 24, 2014 Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 24, 2014 Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with d... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 10, 2014 Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture s... Product does not function as intended up to the expiry date on the product labeling. There is a ... Class II Leica Microsystems, Inc.
Nov 23, 2013 The Abbott m2000sp is an automated system for performing sample preparation f... The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling a... Class II Abbott Molecular
Nov 8, 2013 IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syrin... Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the ... Class II Baxter Healthcare Corp.
Nov 4, 2013 Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap;... There is a potential that the specified mucus specimen traps are not sterile. Use of the affected... Class II Medline Industries Inc
Oct 31, 2013 Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infus... Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly... Class I Hospira Inc.
Oct 31, 2013 Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions incl... Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Enc... Class I Hospira Inc.
Oct 28, 2013 Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient c... Reports of loose bolts in the detector support structure of Symbia and E.CAM systems. Class II Siemens Medical Solutions USA, Inc.
Oct 28, 2013 e.cam line of gamma camera systems Used to detect or image the distributi... Reports of loose bolts in the detector support structure of Symbia and e.cam systems. Class II Siemens Medical Solutions USA, Inc.
Oct 25, 2013 *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE ... Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assemb... Class II Hospira Inc.
Oct 17, 2013 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubin... The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully c... Class II Baxter Healthcare Corp
Oct 16, 2013 The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeCho... The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that... Class II Baxter Healthcare Corp.
Oct 16, 2013 Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid... Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Inte... Class III Nanosphere, Inc.
Oct 10, 2013 The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene S... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 7, 2013 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on... In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the p... Class II Baxter Healthcare Corp.
Sep 25, 2013 Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corp... Incomplete foil seal on one lot of sterile product. Class II Baxter Healthcare Corp.
Sep 24, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD sc... Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Sep 20, 2013 The Vantage Digital Panoramic System delivers high-value features standard on... An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.... Class II Midmark Corp dba Progeny Inc
Sep 18, 2013 Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; V... Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporizat... Class II Richard Wolf Medical Instruments Corp.
Sep 11, 2013 Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscop... The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which... Class II Leica Microsystems, Inc.
Sep 11, 2013 Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. ... The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which... Class II Leica Microsystems, Inc.
Sep 10, 2013 Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, A... Hospira has become aware of customers using the incorrect size Receptal liners with their Recepta... Class II Hospira Inc.
Sep 10, 2013 Dual Luer Lock Cap The device is intended for use as a cap for male or fem... The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging... Class II Baxter Healthcare Corp.
Sep 10, 2013 Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Nu... Hospira has become aware of customers using the incorrect size Receptal liners with their Recepta... Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBL... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BL... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH ... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 9, 2013 *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE P... Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. Class II Hospira Inc.
Sep 4, 2013 Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ... The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinhol... Class II Baxter Healthcare Corp.
Aug 30, 2013 Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured ... Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 Class II Baxter Healthcare Corp.
Aug 28, 2013 *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; **... Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the corr... Class II Hospira Inc.
Aug 28, 2013 *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareF... Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, p... Class II Carefusion 2200 Inc
Aug 26, 2013 Merge Mammo is a multi-modality, vendor-neutral digital mammography workstati... There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo vie... Class II GE Healthcare It
Aug 16, 2013 Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the... The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally an... Class II Siemens Medical Solutions USA, Inc.
Aug 16, 2013 Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of r... The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally an... Class II Siemens Medical Solutions USA, Inc.
Aug 14, 2013 ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industri... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries,... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, 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.