Browse Device Recalls
2,479 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,479 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 2,479 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-1... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-10... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-15... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-911... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-11... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 18, 2026 | Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP1... | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | Class II | Mentor Texas, LP. |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Jan 23, 2026 | Claviculaplate with Angular Stability, with the below descriptions and associ... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 7, 2026 | Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) C... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2)... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) ... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130;... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 5, 2026 | Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI... | Due to a modification by a vendor and may be reinstalled without properly engaging the outside re... | Class II | Raz Design Inc |
| Dec 31, 2025 | Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET... | Under circumstances involving exposure to particular chemicals and mechanical forces, the male lu... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, ... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY,... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | Portex Spinal Tray, Item No. A3729-24 A3595 | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... | Class II | ICU Medical Inc. |
| Dec 19, 2025 | Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P... | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... | Class II | ICU Medical Inc. |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: R... | Needle free access device intended as accessory to vascular access used in hemodialysis or access... | Class II | ICU Medical, Inc. |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 18, 2025 | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784... | Due to product that may contain a void in the material that separates the wire guide and cutting ... | Class II | Wilson-Cook Medical Inc. |
| Dec 15, 2025 | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Presence of particulates in affected devices that can be deposited into breast tissue during use. | Class II | Hologic, Inc |
| Dec 15, 2025 | Plum Duo Infusion System, List Number 40002-04-01 | ICU Medical received one lot of defective primary speakers from our supplier that may fail to pro... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: M... | The console label for affected devices is missing the "DANGER" symbol. | Class II | LEASEIR TECHNOLOGIES SLU |
| Dec 15, 2025 | ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 ... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY,... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 4, 2025 | Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model... | Due to probe bags that may have a compromised or incomplete sterile pouch seal. | Class II | Intuitive Surgical, Inc. |
| Dec 3, 2025 | Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1... | Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Per... | Class II | Boston Scientific Corporation |
| Nov 24, 2025 | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... | Software issue only allows Concentration Limits to be defined to one digit of precision past the ... | Class II | ICU Medical, Inc. |
| Nov 24, 2025 | LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Softwar... | For certain customers, the Change Summary review option ceases to operate as expected for any mig... | Class II | ICU Medical, Inc. |
| Nov 13, 2025 | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der... | Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. | Class II | Microbiologics Inc |
| Oct 10, 2025 | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMa... | Acute circulatory support system pump may not fit into the motor and reports received of the pump... | Class II | Thoratec LLC |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Ca... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) M... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 2, 2025 | IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w... | IV Gravity burette administration set burette component is missing an internal shutoff valve inte... | Class I | ICU Medical, Inc. |
| Oct 1, 2025 | DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 71... | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | CombiDiagnost R90; Model Number: 709031; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
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.