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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
May 3, 2017 Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 17... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 CUSTOM SUTURE PACK; Item Number: US1540 and US1614 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
Apr 17, 2017 Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number:... Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae. Class II Madison Polymeric Engineering
Apr 10, 2017 CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit an... The current secondary packaging, a box, incorrectly states that the product is latex free. The pr... Class II CooperSurgical, Inc.
Apr 3, 2017 Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI ... Product sterility compromised due to breach in sterile barrier package Class II Mederi Therapeutics, Inc
Mar 3, 2017 Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm),... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curi... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile It... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code:... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device t... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device t... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code:... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Feb 8, 2017 BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01 Handle may break during use. Class II Medtronic
Feb 8, 2017 SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 Handle may break during use. Class II Medtronic
Feb 8, 2017 SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01 Handle may break during use. Class II Medtronic
Feb 8, 2017 SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01 Handle may break during use. Class II Medtronic
Feb 8, 2017 BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 Handle may break during use. Class II Medtronic
Jan 26, 2017 Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Ste... Customer reports of the device handset continuing to operate after release of the activation button. Class II COVIDIEN MEDTRONIC
Jan 23, 2017 Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-... Sterility compromised due to breach in sterile barrier Class II Covidien LLC
Jan 23, 2017 Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphe... Sterility compromised due to breach in sterile barrier Class II Covidien LLC
Dec 16, 2016 Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellc... Labeling error: The label indicates the product is latex free, but the headband component include... Class II Covidien LLC
Oct 14, 2016 Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, ... Sterility of the outer surface of the container compromised due to packaging defect. Class II Covidien LLC
Oct 4, 2016 Covidien Clearify Visualization System Item Code: 21-345 Intended to be us... Product sterility is compromised due to breach of the sterile barrier Class II Medtronic
Oct 4, 2016 Best Practices kits containing certain production lots of Clearify Visualizat... Product sterility is compromised due to breach of the sterile barrier Class II Medtronic
Sep 29, 2016 Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Produ... Added Instructions for Use: After application, inspect the Light Glove for barrier integrity Class II Covidien LLC
Sep 29, 2016 Covidien Devon Light Glove packaged in sterile surgical kits Reference: 3114... Added Instructions for Use: After application, inspect the Light Glove for barrier integrity Class II Covidien LLC
Sep 29, 2016 Professional Hospital Supply, Inc Custom Packaging containing the Devon Light... Added Instructions for Use: After application, inspect the Light Glove for barrier integrity Class II Covidien LLC
Sep 15, 2016 Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx,... Image data for a patients image may not be correct Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 25, 2016 Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawi... Products contain international package insert and not the correct USA package insert Class III CooperSurgical, Inc.
Aug 25, 2016 Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freez... Products contain international package insert and not the correct USA package insert Class III CooperSurgical, Inc.
Jul 8, 2016 Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The V... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 T... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 ... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E2581... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: ... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E2583... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 T... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 ... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Va... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code:... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 Th... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E27... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Va... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E25... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R3... Potential for compromise of the package resulting in a breach of the sterile barrier Class II Medtronic

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.