Browse Device Recalls
68 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 68 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 68 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 25, 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/... | A manufacturing issue could lead to a malformed cover tube press which can lead to internal compo... | Class II | Covidien, LP |
| Sep 25, 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/... | A manufacturing issue could lead to a malformed cover tube press which can lead to internal compo... | Class II | Covidien, LP |
| 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 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 |
| 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 |
| 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 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 |
| 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 |
| May 13, 2022 | EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbe... | The affected staplers have the potential for the staple guide to not be securely attached to the ... | Class II | Covidien, LP |
| Dec 22, 2021 | SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code A... | Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the devi... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | 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.