Browse Device Recalls

675 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 675 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 675 FDA device recalls.

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DateProductReasonClassFirm
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensio... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensio... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extension... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 2, 2023 Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytos... Cell Collection Device may be at increased risk of the sponge detaching from the string during re... Class II Covidien, LLC
May 22, 2023 Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuratio... Class II Covidien, LLC
Mar 24, 2023 Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: ... A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy ... Class I Covidien
Mar 22, 2023 VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
Mar 22, 2023 VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
Mar 22, 2023 VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside ... Class II Covidien LP
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 10, 2023 COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. ... Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. Class II Covidien
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 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 7, 2022 MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single... There is a potential leaking condition within the hub of affected devices, due to an inter-lumen ... Class I Covidien LP
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
Nov 23, 2022 COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopi... The product is labeled with the incorrect expiration date. Class II Covidien, LLC
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 19, 2022 Puritan Bennett 560 Ventilator, PB560, CFN 4096600 Medtronic has confirmed six reports from customers outside the US where the ventilator became ino... Class II Covidien Llc
Jun 8, 2022 Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc

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.