Browse Device Recalls
723 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 723 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 723 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 4, 2026 | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2... | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Class II | Koven Technology, Inc. |
| Feb 6, 2026 | Battery Charging Station; Model: 0998-00-0802; | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP ... | Class III | Datascope Corp. |
| Jan 30, 2026 | Tandem pumps are battery-operated infusion pumps capable of both basal and bo... | The Czech language user guide contained multiple translation errors. The most significant error ... | Class II | Tandem Diabetes Care, Inc. |
| Jan 23, 2026 | CS100 IABP. Software Version CS100 IABP Q.01. | The firm has identified that the battery runtime and cycle specifications contained in the device... | Class II | Datascope Corp. |
| Jan 23, 2026 | CS300 IABP. Software Version CS300 IABP C.01. | The firm has identified that the battery runtime and cycle specifications contained in the device... | Class II | Datascope Corp. |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTREC... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTIC... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, ... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY ... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 8, 2025 | Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1... | Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lo... | Class II | Securitas Healthcare LLC |
| Dec 8, 2025 | Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version:... | Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lo... | Class II | Securitas Healthcare LLC |
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system Power Management Board (PMB) Fiel... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... | Class I | GE Medical Systems China Co., Ltd. |
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: ... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... | Class I | GE Medical Systems China Co., Ltd. |
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: ... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... | Class I | GE Medical Systems China Co., Ltd. |
| Nov 12, 2025 | The Stryker CranialMask Tracker is a single-use device consisting of a flexib... | When the device is activated during surgery, the device software issues an error message "Instrum... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2025 | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, i... | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... | Class II | Edan Diagnostics |
| Oct 13, 2025 | MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE a... | Due to battery component overheating while charging resulting in melting of internal components a... | Class II | MRIMed Inc. |
| Oct 9, 2025 | bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| 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 | bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: ... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| 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 9, 2025 | UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imagin... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; Sys... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Mod... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 7, 2025 | SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected ... | Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which c... | Class II | Philips Respironics, Inc. |
| Oct 6, 2025 | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... | Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma... | Class I | Tandem Diabetes Care, Inc. |
| Sep 26, 2025 | BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monito... | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... | Class II | GE Healthcare Finland Oy |
| Sep 3, 2025 | Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Ass... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associ... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Assoc... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: ... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K1... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; A... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K1306... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; A... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K1306... | The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Sep 3, 2025 | Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K13084... | Systems may not perform as intended due to the deterioration of certain internal components (the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
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.