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
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
Dec 2, 2022 Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Oct 20, 2022 NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases wher... Class II CooperSurgical, Inc.
Sep 28, 2022 Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLO... Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... Class II Covidien, LP
Sep 28, 2022 Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA00... Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... Class II Covidien, LP
Aug 12, 2022 Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... Class II CooperSurgical, Inc.
Aug 12, 2022 Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... Class II CooperSurgical, Inc.
Aug 2, 2022 FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm... Sterility with new cotton source not validated Class II Carwild Corporation
Jul 29, 2022 Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, 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.