Browse Device Recalls
717 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 717 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 717 FDA device recalls in CT.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 28, 2024 | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Class II | Covidien, LP |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of ... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of s... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of ... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Feb 14, 2024 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30... | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... | Class II | Covidien, LP |
| Feb 14, 2024 | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... | Class II | Covidien, LP |
| Jan 25, 2024 | Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile,... | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilizat... | Class II | Covidien, LP |
| Jan 9, 2024 | Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Sha... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft a... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft an... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft ... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft a... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and M... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Jan 9, 2024 | Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft an... | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... | Class II | Silex Medical, LLC |
| Dec 20, 2023 | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), ... | The firm has become aware of a sudden increase in complaints for three associated lots. Performan... | Class II | CooperSurgical, Inc. |
| Aug 29, 2023 | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quan... | Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual ki... | Class II | CooperSurgical, Inc. |
| Mar 1, 2023 | Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K),... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Mar 1, 2023 | Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT ... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Mar 1, 2023 | Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURG... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Mar 1, 2023 | Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sl... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Feb 14, 2023 | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on ... | A component of a sub-assembly used in the affected AEDs had not undergone durability and reliabi... | Class II | Defibtech, LLC |
| Feb 13, 2023 | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5... | It has come to CooperSurgical's attention that the affected Product may contain a medium other th... | Class II | CooperSurgical, Inc. |
| Jan 25, 2023 | Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT | Affected lots have the potential for a broken sled vane, which may cause the reload to misfire le... | Class II | Covidien, LP |
| Jan 16, 2023 | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-... | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual | Class II | Hologic, Inc. |
| Jan 11, 2023 | Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- ... | Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, a... | Class II | Covidien, LP |
| Dec 15, 2022 | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy o... | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use... | Class II | CooperSurgical, Inc. |
| Dec 8, 2022 | Detect Covid-19 Test Product/Model Number: 21205 | There is an increased chance that the tests from affected lots may give false negative results. H... | Class II | Detect Headquarters |
| Dec 2, 2022 | Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURG... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Surgipro II Monofilament Polypropylene Sutures Product Description Model Num... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSI... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Surgidac Uncoated Braided Polyester suture Product Description D-17... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TIC... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 C... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | Class II | Covidien, LP |
| Dec 2, 2022 | Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM... | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... | 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.