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 30, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 4, 2020 | Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - ... | Canisters potentially contain an oversized O-ring that cannot be installed into the mating conne... | Class II | Cardinal Health 200, LLC |
| Jun 4, 2020 | Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usa... | Canisters potentially contain an oversized O-ring that cannot be installed into the mating conne... | Class II | Cardinal Health 200, LLC |
| Jun 2, 2020 | Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only | A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a... | Class II | Baxter Healthcare Corporation |
| May 28, 2020 | Thora-Para 5 Fr Non-Valved Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection ... | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection ... | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 6 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 5 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| 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. |
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.