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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 13, 2020 | Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a... | Luminex has determined that three (3) separate test fixtures used by field service engineers to s... | Class II | Luminex Corporation |
| Oct 5, 2020 | EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 | The cross-reactivity of the device may present an increased level of potential false positives. S... | Class II | Thera Test Laboratories, Inc. |
| Oct 1, 2020 | The Quidel Triage BNP Calibrators | Product compromised during shipment. | Class II | Medline Industries Inc |
| Sep 15, 2020 | Quick Release Gait Belt, 60 | The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and I... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAM... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage:... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage:... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NA... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NA... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Us... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 1, 2020 | ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL T... | There have been reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Aug 14, 2020 | Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the de... | This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2020 | Central Line Dressing Change Tray | Potential of incomplete seals impacting the sterility of the kit. | Class II | Medline Industries Inc |
| Jul 30, 2020 | EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 | Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not... | Class II | Thera Test Laboratories, Inc. |
| Jul 29, 2020 | PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s... | A degradation defect was found that could lead to holes and donning tears at the folding area aro... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2020 | PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s... | A degradation defect was found that could lead to holes and donning tears at the folding area aro... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2020 | PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s... | A degradation defect was found that could lead to holes and donning tears at the folding area aro... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2020 | PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s... | A degradation defect was found that could lead to holes and donning tears at the folding area aro... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2020 | PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s... | A degradation defect was found that could lead to holes and donning tears at the folding area aro... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2020 | PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s... | A degradation defect was found that could lead to holes and donning tears at the folding area aro... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2020 | PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s... | A degradation defect was found that could lead to holes and donning tears at the folding area aro... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2020 | PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s... | A degradation defect was found that could lead to holes and donning tears at the folding area aro... | Class II | Cardinal Health 200, LLC |
| Jul 28, 2020 | Control, Calibrator Verified, Triage BNP, Model ALR88755 | Product was shipped with refrigeration (ice) instead of frozen (dry ice). | Class II | Medline Industries Inc |
| Jul 9, 2020 | Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are si... | Potential risk of brush detachment during cleaning. | Class II | Medline Industries Inc |
| Jul 6, 2020 | Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usa... | Insufficient amount of antibody without an error message or alarm | Class II | Sysmex America, Inc. |
| Jun 30, 2020 | ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ... | There are reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Jun 30, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 ... | There are reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| 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 |
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.