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
Jul 8, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil ... Class II Baxter Healthcare Corp.
Jun 18, 2013 LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE... Hospira has received reports of customers experiencing air-in-line alarms related to administrati... Class II Hospira Inc.
Jun 17, 2013 Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 17, 2013 Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 11, 2013 The Centricity PACS Workstation is intended for use as a primary diagnostic a... GE has recently become aware of potential issues due to out of context issues associated with spe... Class II GE Healthcare It
Jun 10, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used... Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administrat... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for ... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous ... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor:... Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implement... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Multirate Infusor Devices. Indicated for the intravenous admin... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Bax... Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implement... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Intermate Infusion Pump. Indicated for the intravenous adminis... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Regional Analgesia Infusor System with Patient Control. Indica... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Intermate Infusion Pump. Indicated for the intravenous adminis... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
May 24, 2013 AMICUS Exchange Kit; Product Usage: This kit is designed for use with th... Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339... Class II Fenwal Inc
May 21, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Cor... leaking pouches Class II Baxter Healthcare Corp.
May 15, 2013 Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Conta... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Prod... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8... The data printed on the thermal printer may omit a digit or decimal point in the results or sampl... Class II Sysmex America Inc
May 15, 2013 Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Contai... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 10, 2013 Responder 5 is a nurse call communication system that connects patients with ... A counterfeited electronic component was identified in the products affected. The component, a da... Class II Rauland-Borg Corp
Apr 22, 2013 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) ... CareFusion has received four (4) customer reports of a component (oxygen connector) within the re... Class II Carefusion 2200 Inc
Apr 19, 2013 Centricity Enterprise Archive is a software product for receiving, archiving ... GE Healthcare has become aware of a potential data loss issue associated with empty path names re... Class II Ge Healthcare It
Apr 16, 2013 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical lase... A defect in the controller board can lead to the condenser to the video monitor becoming too warm... Class II Ziemer Usa Inc
Apr 15, 2013 Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; sing... Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbili... Class II Cypress Medical Products LLC
Apr 4, 2013 LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060... An LPC Fine Mesh Cassette failed to stay closed during processing operations. Class II Leica Microsystems, Inc.
Apr 1, 2013 List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Bloo... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Apr 1, 2013 List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 In... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Apr 1, 2013 List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP;... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Apr 1, 2013 List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, No... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Apr 1, 2013 List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE ... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Apr 1, 2013 List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Conver... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Apr 1, 2013 List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection S... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Apr 1, 2013 List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Apr 1, 2013 List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood... It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... Class I Hospira Inc.
Mar 31, 2013 The UF-1000i is a fully automated urine particle analyzer intended for vitro ... The current Century Break patch did not contain the same setting for the Century Break year for b... Class II Sysmex America, Inc.
Mar 28, 2013 The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analy... 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellit... Class III Abbott Molecular
Mar 28, 2013 A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol... Customers have reported that when separating an individual package from its attached grouping, th... Class II Baxter Healthcare Corp.
Mar 28, 2013 A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only,... Customers have reported that when separating an individual package from its attached grouping, th... Class II Baxter Healthcare Corp.
Mar 28, 2013 A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0... Customers have reported that when separating an individual package from its attached grouping, th... Class II Baxter Healthcare Corp.
Mar 28, 2013 A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0... Customers have reported that when separating an individual package from its attached grouping, th... Class II Baxter Healthcare Corp.
Mar 26, 2013 Presource PBDS, General Laparoscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Knee Arthroscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Extremity, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Total Knee, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Major Abdominal, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Total Joint, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services
Mar 26, 2013 Presource PBDS, Total Hip, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... Class I Cardinal Health, Medical Products & Services

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.