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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.