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
May 20, 2020 Leica ARveo and M530 OH6 microscope systems. Possible unintended interruption of surgical procedures due to equipment shutdown, related to cha... Class II Leica Microsystems, Inc.
May 18, 2020 Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical bl... Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handl... Class II Carefusion 2200 Inc
Apr 17, 2020 Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set... Potential disconnection of tubing set. Class II Baxter Healthcare Corporation
Apr 17, 2020 Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product ... Potential disconnection of tubing set. Class II Baxter Healthcare Corporation
Apr 17, 2020 Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single... Potential disconnection of tubing set. Class II Baxter Healthcare Corporation
Apr 17, 2020 Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysi... Potential disconnection of tubing set. Class II Baxter Healthcare Corporation
Apr 7, 2020 Prismaflex Control Unit Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distr... Class II Baxter Healthcare Corporation
Apr 3, 2020 ImmersiveView software version 2.1 Product Usage: ImmersiveView is intend... Observed an internal repetitive software glitch in ImmersiveView. Class III Immersivetouch Inc
Apr 1, 2020 ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... Class III Abbott Laboratories
Apr 1, 2020 ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis ... Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... Class III Abbott Laboratories
Apr 1, 2020 ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide... Class III Abbott Laboratories
Mar 10, 2020 ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, Americ... Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. Class II Northgate Technologies, Inc.
Mar 10, 2020 AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usag... Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. Class II Northgate Technologies, Inc.
Mar 10, 2020 Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are... As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompat... Class II Northgate Technologies, Inc.
Mar 9, 2020 Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... Medline identified that there may be a potential for voids in the packaging seal and loss of ster... Class II Medline Industries Inc
Mar 9, 2020 The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receive... Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an ... Class II Sysmex America, Inc.
Mar 5, 2020 GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to... The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... Class II Baxter Healthcare Corporation
Mar 5, 2020 GEM Microvascular Anastomotic Coupler Devices s intended to be used in the an... The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... Class II Baxter Healthcare Corporation
Mar 5, 2020 GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to ... The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... Class II Baxter Healthcare Corporation
Feb 10, 2020 Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 10, 2020 Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 10, 2020 Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 6, 2020 Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... Class II Baxter Healthcare Corporation
Feb 6, 2020 Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... Class II Baxter Healthcare Corporation
Feb 6, 2020 Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... Class II Baxter Healthcare Corporation
Feb 6, 2020 Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... Class II Baxter Healthcare Corporation
Feb 6, 2020 Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... Class II Baxter Healthcare Corporation
Feb 6, 2020 Prismaflex System, Prismaflex Control Unit Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... Class II Baxter Healthcare Corporation
Jan 31, 2020 Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Ca... The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not... Class II Cardinal Health 200, LLC
Jan 31, 2020 Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Ca... The kits contained recalled surgical gowns. The gowns were manufactured at locations that did no... Class II Cardinal Health 200, LLC
Jan 30, 2020 LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR -... Observed leakage at the sample port assembly which could potentially lead to loss of perfusion so... Class II Organ Recovery Systems, Inc.
Jan 21, 2020 Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e... The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... Class II Medline Industries Inc
Jan 21, 2020 Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI... The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... Class II Medline Industries Inc
Jan 21, 2020 Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimen... When excessive amounts of urine spills on the rack transport track and reaches the electrical co... Class II Sysmex America, Inc.
Jan 11, 2020 AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 2XLARGE, Gown. Item Code 9578 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health

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.