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.

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DateProductReasonClassFirm
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.
Aug 14, 2013 CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline I... 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 STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries,... 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 PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., M... 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 STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., M... 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 STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., M... 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 PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., M... 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 TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., M... 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 HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Indus... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Jul 17, 2013 Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 90... Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System... Class II Hospira Inc.
Jul 15, 2013 ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm T... Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Class II Endoplus, Inc.
Jul 15, 2013 ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm At... Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Class II Endoplus, Inc.
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.

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.