Browse Device Recalls
690 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 690 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 690 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 24, 2026 | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM033... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING ... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; ... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 13, 2026 | EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 108... | The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them... | Class II | Covidien, LLC |
| Apr 23, 2026 | Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 108845... | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) p... | Class II | Covidien LLC |
| Apr 23, 2026 | Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM RE... | Temperature probe devices lack FDA clearance. | Class II | Covidien LLC |
| Apr 23, 2026 | Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 | Temperature probe devices lack FDA clearance. | Class II | Covidien LLC |
| Apr 23, 2026 | Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 | Temperature probe devices lack FDA clearance. | Class II | Covidien LLC |
| Apr 15, 2026 | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 1700... | The presence of holes in the pouch may compromise the package s ability to maintain the sterile b... | Class II | Covidien, LP |
| Apr 15, 2026 | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI ... | Due to customer complaint regarding incorrect display box labeling. | Class II | Covidien LLC |
| Jan 30, 2026 | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: ... | Due to complaints and investigations stating that alarms from the primary patient bedside monitor... | Class II | Covidien LLC |
| 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 |
| Jun 23, 2025 | Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 1000594... | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay... | Class II | Covidien |
| May 21, 2025 | Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT... | Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which m... | Class I | Covidien |
| Feb 26, 2025 | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner C... | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the oute... | Class I | Covidien |
| Sep 19, 2024 | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH0... | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure test... | Class II | Covidien LP |
| Jul 9, 2024 | McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the deign threshold which... | Class I | Covidien |
| Jul 9, 2024 | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | IFU update to address device's battery handling information. | Class II | Covidien |
| Jul 9, 2024 | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the deign threshold which... | Class I | Covidien |
| Jun 24, 2024 | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... | Any single affected ventilator should only be used for the 10- year labelled service life, but if... | Class I | Covidien |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Co... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Na... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 25, 2024 | EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only | Due to saline conductivity issues, their is a potential that dilation catheters may provide inacc... | Class II | Covidien, LLC |
| 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 |
| Mar 15, 2024 | Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Mar 15, 2024 | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | 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 21, 2024 | Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 | Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detec... | Class II | Covidien |
| 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 |
| Jan 9, 2024 | Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC | manufacturing defects to sensor cable connectors may result in error codes or non-functioning c... | Class II | Covidien |
| Jan 9, 2024 | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC | manufacturing defects to sensor cable connectors may result in error codes or non-functioning c... | Class II | Covidien |
| Dec 21, 2023 | Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 ... | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... | Class II | Covidien LP |
| Dec 21, 2023 | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 8... | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... | Class II | Covidien LP |
| Nov 16, 2023 | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10G... | Due to software issue, New systems may exhibit an error which may prohibit use of new systems res... | Class II | Covidien |
| Nov 16, 2023 | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -int... | Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentia... | 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.