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 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code N... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code N... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, R... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pi... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, ... Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Jan 7, 2022 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... Class II Baxter Healthcare Corporation
Dec 29, 2021 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pro... There is the potential for reduced or non-delivery of medication, in some cases without alerting ... Class I Baxter Healthcare Corporation
Dec 29, 2021 Baxter Spectrum IQ Infusion Pumps, Product code 3570009. There is the potential for reduced or non-delivery of medication, in some cases without alerting ... Class I Baxter Healthcare Corporation
Dec 29, 2021 MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 20, 2021 bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventila... Potential cessation in ventilation can occur under specific conditions. Class I Vyaire Medical
Dec 15, 2021 CURAD REUSABLE GEL HOT/COLD PACK The product contains natural rubber latex but the label states that it does not. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is an issue with the installation of updated camera firmware on the system. Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a software defect that can cause the Amplification Detection clamp CLEAN position to be ... Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a software issue associated with the ability to properly complete a Field Service Engine... Class II Abbott Molecular, Inc.
Dec 6, 2021 Alinity m System, Part No. 08N53-002 There is a potential for abnormal (non-sigmoidal) amplification curves. Class II Abbott Molecular, Inc.
Dec 1, 2021 Michels Transport Medium, 20ML Prefilled Cont Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 1, 2021 Premier Rotaclone, Rx only Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 1, 2021 HARDY DIAGNOSTICS CatScreen, 25dsk/vial Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 30, 2021 Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 Affected product was shipped from the warehouse at room temperature instead of the required refri... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 16, 2021 Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and... Increase in premature device failures Class II Ohio Medical Corporation
Nov 3, 2021 Leica Microsystems M220 F12 Microscope Systems In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Mi... Class II Leica Microsystems, Inc.
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-li... Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long ... Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Oct 27, 2021 Neuro Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 27, 2021 Bedside PICC CDS Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 27, 2021 Major Vascular CDS Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 27, 2021 Venous Access Pack-LF Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 27, 2021 EVLP Convenience Pack/Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 25, 2021 Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M... The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low s... Class II Northgate Technologies, Inc.
Oct 22, 2021 ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 Product was shipped from a Medline warehouse to a customer at room temperature instead of refrige... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 29, 2021 Hemodialysis Delivery System, Software Version 2.x. If the operator initiates therapy with a saved prescription profile and makes a change to the pr... Class II Baxter Healthcare Corporation
Sep 10, 2021 Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) The belt may fail at lower loads than the labeled 600lbs. Class II Kinsman Enterprises Inc
Sep 2, 2021 Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Ali... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alin... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Applic... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Sep 2, 2021 Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Applicat... There is a potential for false positive results. Class I Abbott Molecular, Inc.
Aug 18, 2021 Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultr... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Scrip Inc
Aug 18, 2021 Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultr... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Scrip 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.