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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 17, 2014 | Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corp... | Inadequate iodine and packaging related defects. | Class II | Baxter Healthcare Corp. |
| Jun 11, 2014 | Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Asse... | Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the p... | Class II | Hospira Inc. |
| Jun 10, 2014 | EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-... | If the universal ingredient (UI) in an active configuration is changed using the Configuration Ed... | Class II | Baxter Healthcare Corp. |
| Jun 6, 2014 | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The ... | Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg... | Class II | Hospira Inc. |
| Jun 5, 2014 | DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall... | There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing d... | Class II | Briggs Medical Service Company d.b.a. Mabis |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| Apr 30, 2014 | HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL a... | HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calib... | Class II | Abbott Laboratories |
| Apr 28, 2014 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. ... | Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2014 | Baxter Amia Automated PD systems are used in the treatment of adult renal fai... | System error 01779 is produced when the battery cannot be charged due to specific voltage differe... | Class II | Baxter Healthcare Corp. |
| Apr 23, 2014 | Symbia E camera system. Emission Computed Tomography System used to detect o... | Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear cast... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 23, 2014 | e.cam camera system. Emission Computed Tomography System used to detect or i... | Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear cast... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 18, 2014 | Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a t... | Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry d... | Class II | Leica Microsystems, Inc. |
| Apr 17, 2014 | The Patient Control Module (PCM) is used in conjunction with a Baxter infusor... | Potential for device malfunction resulting in flow when the device should not be flowing | Class II | Baxter Healthcare Corp. |
| Apr 17, 2014 | Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed usi... | Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an ele... | Class II | Nanosphere, Inc. |
| Apr 8, 2014 | e.cam -emission computed tomography system Used to detect or image the dis... | There is a potential for patient finger injury on the e.cam systems. | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 3, 2014 | AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for p... | Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increase... | Class II | Baxter Healthcare Corp. |
| Apr 3, 2014 | The Centricity PACS Workstation is intended for use as a primary diagnostic a... | It has been identified that in a reject image workflow where multiple studies are simultaneously ... | Class II | GE Healthcare |
| Mar 25, 2014 | LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Consta... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira Inc. |
| Mar 25, 2014 | LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira Inc. |
| Mar 25, 2014 | LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); Fo... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira Inc. |
| Mar 25, 2014 | LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compat... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira Inc. |
| Mar 25, 2014 | LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Rese... | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... | Class II | Hospira Inc. |
| Mar 20, 2014 | Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrap... | This lot did not go through the correct sterilization procedures. This product may potentially be... | Class II | Medline Industries Inc |
| Mar 18, 2014 | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists... | Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when ... | Class III | Nanosphere, Inc. |
| Mar 5, 2014 | Symbia T and Symbia T2 computer tomography systems. These systems are used to... | There are confirmed reports of a component coming loose inside the CT enclosure and damaging the ... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 26, 2014 | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL... | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GS... | Class II | Leica Microsystems, Inc. |
| Feb 25, 2014 | LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inc... | Hospira identified an incorrect lower lid (set component) had been supplied and was being used du... | Class II | Hospira Inc. |
| Feb 19, 2014 | Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes,... | The bar code that is printed on the Master Carton label does not correspond to the product code f... | Class III | Medefil Incorporated |
| Feb 18, 2014 | GemStar Docking Station, used with GemStar infusion pump, in combination with... | There are two situations that may occur when using the GemStar Docking Station, List Number 13075... | Class I | Hospira Inc. |
| Feb 12, 2014 | ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (... | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential... | Class II | Abbott Laboratories |
| Feb 12, 2014 | ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibra... | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential... | Class II | Abbott Laboratories |
| Feb 7, 2014 | SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... | Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... | Class I | Baxter Healthcare Corp. |
| Feb 3, 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... | Class I | Hospira Inc. |
| Feb 3, 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... | Class I | Hospira Inc. |
| Jan 31, 2014 | GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (... | The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump wi... | Class II | Hospira Inc. |
| Jan 24, 2014 | LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusi... | There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... | Class II | Hospira Inc. |
| Jan 24, 2014 | Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion... | There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... | Class II | Hospira Inc. |
| Jan 24, 2014 | Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with d... | There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... | Class II | Hospira Inc. |
| Jan 10, 2014 | Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture s... | Product does not function as intended up to the expiry date on the product labeling. There is a ... | Class II | Leica Microsystems, Inc. |
| Nov 23, 2013 | The Abbott m2000sp is an automated system for performing sample preparation f... | The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling a... | Class II | Abbott Molecular |
| Nov 8, 2013 | IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syrin... | Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the ... | 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.