Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Howmedica Osteonics Corp.
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-e...
Medical Devices·320 affected·Nov 12, 2025
High RiskFDA
Cardinal Health 200, Llc
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T...
Medical Devices·251,165 affected·Nov 12, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Medical Devices·94 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Medical Devices·2,626 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Medical Devices·437 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Medical Devices·118 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Medical Devices·0 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Medical Devices·207 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Medical Devices·9 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Medical Devices·6,949 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Medical Devices·1,634 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Medical Devices·899 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Medical Devices·1 affected·Nov 11, 2025
CriticalFDA
Avid Medical, Inc.
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Medical Devices·52 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Medical Devices·91 affected·Nov 11, 2025
CriticalFDA
Avid Medical, Inc.
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Medical Devices·132 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Medical Devices·7,426 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Medical Devices·0 affected·Nov 11, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Medical Devices·1 affected·Nov 11, 2025
High RiskFDA
Beckman Coulter, Inc.
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyan...
Medical Devices·76,098 affected·Nov 10, 2025
High RiskFDA
Path
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Medical Devices·0 affected·Nov 6, 2025
High RiskFDA
Cepheid
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Medical Devices·9,880 affected·Nov 5, 2025
High RiskFDA
Diasol, Inc
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 l...
Medical Devices·2,200 affected·Nov 5, 2025
High RiskFDA
Diasol, Inc
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 l...
Medical Devices·186,000 affected·Nov 5, 2025
High RiskFDA
Diasol, Inc
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 l...
Medical Devices·4,400 affected·Nov 5, 2025
High RiskFDA
Datascope Corp.
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Medical Devices·47 affected·Nov 4, 2025
High RiskFDA
Datascope Corp.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Medical Devices·11,470 affected·Nov 4, 2025
High RiskFDA
Get Tested International Ab
Food Intolerance Test Small
Medical Devices·5 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Vitamin D-Test
Medical Devices·1,557 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Candida Test
Medical Devices·109 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Organic Acids Profile Test Large
Medical Devices·1 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Allergy Test IgE
Medical Devices·71 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Allergy test Small
Medical Devices·76 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
GI Microbiome Profile XL
Medical Devices·3 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Illegally Marketed
Medical Devices·1 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
HPV Antigen Test
Medical Devices·258 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Sperm Test
Medical Devices·33 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Mycoplasma test, IgG and IgM
Medical Devices·23 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Parasite Test
Medical Devices·94 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Adrenal Test
Medical Devices·17 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Neurotransmitters Plus
Medical Devices·18 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Pollen Allergy Test
Medical Devices·10 affected·Nov 3, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Medical Devices·15,862 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Alcohol (ALC) Test Saliva
Medical Devices·1 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Gut Microbiome Test XL
Medical Devices·4 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Pet Allergy Test
Medical Devices·29 affected·Nov 3, 2025
RecallFDA
Orthofix U.s. Llc
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿...
Medical Devices·14,201 affected·Nov 3, 2025
High RiskFDA
Get Tested International Ab
Urinary Tract Infection Test
Medical Devices·40 affected·Nov 3, 2025