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
Jan 23, 2013 Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product... Affected products have a labeled expiration date of one year too long. Class III Bion Enterprises Ltd
Jan 23, 2013 Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Pro... Affected products have a labeled expiration date of one year too long. Class III Bion Enterprises Ltd
Jan 21, 2013 Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and... The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the ... Class II Arjo, Inc. dba ArjoHuntleigh
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removab... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double ... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removabl... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 14, 2012 Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm... Some of the individual extension set packages were improperly sealed, compromising the sterility ... Class II Baxter Healthcare Corp.
Dec 12, 2012 Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) an... The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely dep... Class II Abbott Laboratories
Dec 10, 2012 Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein th... The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. Class II Arjo, Inc. dba ArjoHuntleigh
Dec 7, 2012 Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; ... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 7, 2012 Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045;... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 7, 2012 Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest,... The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break... Class II Hospira Inc.
Dec 4, 2012 Abbott m2000sp Instrument; an automated fluid handling system for performing ... An issue with the m2000sp Instrument software has been identified whereby, after a series of step... Class II Abbott Molecular
Nov 20, 2012 The Centricity Laboratory System is intended to be an information system desi... If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different value... Class II GE Healthcare It
Nov 20, 2012 The Centricity Laboratory System is intended to be an information system desi... GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Labor... Class III GE Healthcare It
Nov 20, 2012 Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System... The Centricity Laboratory removes free-text notes on a master panel when the user deletes the sla... Class II GE Healthcare It
Nov 16, 2012 Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in elec... ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh section... Class II Arjo, Inc. dba ArjoHuntleigh
Nov 16, 2012 Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB,... ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh section... Class II Arjo, Inc. dba ArjoHuntleigh
Nov 16, 2012 Centricity Enterprise Archive is a software product for receiving, archiving ... There is a potential for data loss associated with empty path names resulting from HL-7 updates w... Class II Ge Healthcare It
Nov 15, 2012 GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Ar... While merging exams in a test instance, merges carry forward in the production system, when the m... Class II GE Healthcare It
Nov 14, 2012 Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Tr... RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining i... Class II Leica Microsystems, Inc.
Nov 13, 2012 Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissu... The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the ... Class II Leica Microsystems, Inc.
Nov 8, 2012 Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... Class II Medline Industries Inc
Oct 26, 2012 Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Oct 26, 2012 Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Conn... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Oct 26, 2012 Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Oct 23, 2012 The Siemens Symbia T series is intended to aid in detecting, localizing, diag... There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. Class II Siemens Medical Solutions USA, Inc.
Oct 23, 2012 The Siemens Symbia S series is intended to aid in detecting, localizing, diag... There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. Class II Siemens Medical Solutions USA, Inc.
Oct 2, 2012 Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Commun... GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the... Class II GE Healthcare It
Sep 20, 2012 Medline Total Knee CDS; a single patient prescription procedure pack and disp... The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pa... Class II Medline Industries Inc
Sep 15, 2012 Centricity PACS System versions 3.X and higher and 4.X and higher Product Us... There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam tra... Class II Ge Healthcare It
Sep 7, 2012 Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Bur... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Aug 31, 2012 Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro M... Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at ti... Class II Accuro Medical Product LLC
Aug 29, 2012 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,... Class I Hospira Inc.
Aug 29, 2012 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response,... Class I Hospira Inc.
Aug 28, 2012 Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers a... Embedded iron oxide glass defect which may have the potential to break off into the solution. Class II Hospira Inc.
Aug 2, 2012 E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the... Class II Kreg Medical Inc.
Aug 2, 2012 Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-0... Reports of leaking during filling and administration. Class II Hospira, Inc.
Jul 13, 2012 Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch wi... The float valve in the burette sticks to the burette wall and does not open or close properly. Class II Hospira Inc.
Jul 13, 2012 AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), auto... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutritio... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I 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.