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.

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DateProductReasonClassFirm
Nov 22, 2016 AbbVie PEG Kit 20 FR AbbVie is issuing an urgent field correction notification due to an increased number of reports o... Class II AbbVie Inc.
Nov 21, 2016 Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 5... Device could cause a patient overpressure situation without any visual or auditory indication or ... Class II Northgate Technologies, Inc.
Oct 20, 2016 NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cass... Incorrect hCG results Class II Ekla Corporation
Oct 12, 2016 GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1... Potential presence of particulate matter on the blood side of the dialyzer Class II Baxter Healthcare Corp.
Oct 11, 2016 ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for t... Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHIT... Class II Abbott Laboratories
Sep 28, 2016 Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum In... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... Class II Baxter Healthcare Corp.
Sep 28, 2016 sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... Class II Baxter Healthcare Corp.
Sep 28, 2016 V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA S... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Ca... Class II Baxter Healthcare Corp.
Sep 23, 2016 V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, vario... Potential risk associated with corrosion demonstrated on the distraction screw surface. Class II Cardinal Health 200, LLC
Aug 10, 2016 Rigid Suction Canister 3000 CC and 2000 CC. Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure dur... Class II Medline Industries Inc
Aug 5, 2016 e.cam and Symbia E gamma camera systems with patient beds To detect or ima... "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up... Class II Siemens Medical Solutions USA, Inc.
Jul 28, 2016 Hospira MedNet Medication Management Suite software, version 6.1, List Number... Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result... Class II Hospira Inc., A Pfizer Company
Jul 20, 2016 BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, ... Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specif... Class II Cardinal Health
Jul 1, 2016 Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain pl... There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) resu... Class II Sysmex America Inc
Jul 1, 2016 DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot ... BD, formerly CareFusion, has identified a potential risk associated with a weld failure which cou... Class I Carefusion 2200 Inc
Jun 29, 2016 Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored... The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... Class II Carefusion 2200 Inc
Jun 29, 2016 Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module ... The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... Class II Carefusion 2200 Inc
Jun 27, 2016 The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sam... Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as mi... Class II Cardinal Health
Jun 24, 2016 Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUA... Class II Baxter Healthcare Corp.
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.

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.