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
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
Nov 6, 2023 Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100M... Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside... Class I Nurse Assist, LLC
Sep 28, 2023 Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 Defective video laryngoscopes that did not pass quality tests established for the product, that w... Class I Covidien
Aug 22, 2023 Puritan Bennett Cuff Pressure Manager, REF: 180-03 Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes t... Class II Covidien
Aug 22, 2023 Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implan... Class II Covidien LP
Aug 10, 2023 McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, R... Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in ... Class II Covidien
Aug 10, 2023 McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, R... Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in ... Class II Covidien
Aug 3, 2023 MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible wit... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Gen... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 S... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
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, 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, 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, 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, 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

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.