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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jul 13, 2012 | AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; aut... | 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 High Speed Compounder System, product 2M8077; automated nutrition com... | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... | Class I | Baxter Healthcare Corp. |
| Jul 6, 2012 | Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic ... | Baxter discovered that a Baxter technical service representative was providing incorrect instruct... | Class II | Baxter Healthcare Renal Div |
| Jul 3, 2012 | Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral so... | The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR... | Class II | Chicago X-Ray Systems, Inc. |
| Jun 29, 2012 | Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... | ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Jun 29, 2012 | Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Prod... | ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Jun 29, 2012 | Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... | ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Jun 15, 2012 | Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... | Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety ri... | Class II | Ge Healthcare It |
| Jun 4, 2012 | Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems... | Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reducti... | Class II | Leica Microsystems, Inc. |
| Jun 1, 2012 | Sysmex XE-2100 Automated Hematology System; an automated differential cell co... | There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... | Class II | Sysmex America, Inc. |
| Jun 1, 2012 | Sysmex XE-5000 Automated Hematology System; an automated differential cell co... | There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... | Class II | Sysmex America, Inc. |
| Jun 1, 2012 | Sysmex XE-2100C Automated Hematology System; an automated differential cell c... | There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... | Class II | Sysmex America, Inc. |
| May 30, 2012 | ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (... | The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Ab... | Class II | Abbott Laboratories |
| May 29, 2012 | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an ... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 Inc |
| May 29, 2012 | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated;... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 Inc |
| May 29, 2012 | AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; ... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 Inc |
| Apr 19, 2012 | The GE Centricity Web; Software Version 3.0x, is intended for use under the d... | GE Healthcare has become aware of an issue associated with rejected images using the WADO protoco... | Class II | Ge Healthcare It |
| Apr 11, 2012 | Symbia E is a multi-purpose SPECT system used to detect or image the distribu... | Radial motor drives replaced during a customer service action were incorrectly assembled backwards. | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 11, 2012 | E.CAM emission computed tomography system used to detect or image the distrib... | Radial motor drives replaced during a customer service action were incorrectly assembled backwards. | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 5, 2012 | Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira 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.