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.

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DateProductReasonClassFirm
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.