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.

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DateProductReasonClassFirm
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.