Browse Device Recalls
709 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 709 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 709 FDA device recalls in CT.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 25, 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/... | A manufacturing issue could lead to a malformed cover tube press which can lead to internal compo... | Class II | Covidien, LP |
| Sep 25, 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/... | A manufacturing issue could lead to a malformed cover tube press which can lead to internal compo... | Class II | Covidien, LP |
| Aug 29, 2025 | NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalo... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Jun 11, 2025 | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for us... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Jun 11, 2025 | Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Con... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Jun 11, 2025 | Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. End... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Mar 18, 2025 | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item nu... | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Med... | Class II | Defibtech, LLC |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K2401... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Nu... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: ... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Oct 22, 2024 | Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx ... | Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... | Class II | Carwild Corporation |
| Oct 22, 2024 | Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of ... | Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... | Class II | Carwild Corporation |
| Oct 22, 2024 | Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgi... | Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... | Class II | Carwild Corporation |
| Oct 14, 2024 | Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: L... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline... | Within the Irish Market, a Field Safety Notice is being issued due to a select number of authoriz... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: ... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifel... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Jul 31, 2024 | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 | During the manufacturing process the devices were laser-marked with the incorrect part number. | Class II | CooperSurgical, Inc. |
| Jul 31, 2024 | Stainless Steel Sims Uterine Sound, Part Number 64-601 | During the manufacturing process the devices were laser-marked with the incorrect part number. | Class II | CooperSurgical, Inc. |
| Jul 12, 2024 | RMU-2000 Automated Chest Compression Device | Problem in the device's motor may cause the device to stop compressions. This may lead to a delay... | Class I | Defibtech, LLC |
| Jun 5, 2024 | Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections ... | Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... | Class II | MICROspecialties, Inc. |
| Jun 5, 2024 | Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalm... | Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... | Class II | MICROspecialties, Inc. |
| Jun 5, 2024 | Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injecti... | Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... | Class II | MICROspecialties, Inc. |
| Jun 5, 2024 | Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injectio... | Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... | Class II | MICROspecialties, Inc. |
| Apr 15, 2024 | Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal... | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple li... | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
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.