Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIMycoplasma test, IgG and IgM
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIMPOX Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIMenopause (FSH) 2 Tests
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IILyme Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIIron Deficiency Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIHPV Antigen Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIHerpes (HSV-1 & HSV-2) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIH pylori (Peptic ulcer) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIGonorrhea test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIFemale Fertility Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIFecal Occult Blood Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIEpstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIDrug Test Small (4 substances)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIIllegally Marketed
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIDiabetes HbA1c Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IID-Dimer Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIChlamydia Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IICandida Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIBlood Type Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIAlcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceMedtronic, Inc.Class IIAurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 2025-12-10FDA-DeviceEnterix, Inc.Class IIInSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
- 2025-12-10FDA-DeviceFresenius Kabi USA, LLCClass IIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- 2025-12-03FDA-DeviceCepheidClass IIXpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
- 2025-12-03FDA-DeviceINTELERAD MEDICAL SYSTEMS INCORPORATEDClass IIIntelePACS - InteleConnect / TechPortal
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
- 2025-12-03FDA-DeviceDJO, LLCClass IICold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
- 2025-12-03FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass IIIsoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic va
Potential for anesthesia leakage.
- 2025-12-03FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass IISevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic v
Potential for anesthesia leakage.
- 2025-12-03FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.
- 2025-12-03FDA-DeviceB Braun Medical IncClass IIIV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 110 IN.; Catalog Number: 490566.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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