FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 6 of 520
Low Dec 24, 2025
Cardiosave Hybrid
Datascope Corp.
Moderate Dec 24, 2025
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product D…
Rocket Medical Plc
Critical Dec 24, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Fresenius Kabi USA, LLC
Moderate Dec 24, 2025
5008X CAREsystem +CLiC +CDX;
Fresenius Medical Care Holdings, Inc.
Moderate Dec 24, 2025
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Produc…
Rocket Medical Plc
Moderate Dec 24, 2025
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Spe…
Copan Italia
Moderate Dec 24, 2025
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product D…
Rocket Medical Plc
Moderate Dec 24, 2025
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Si…
DSAART LLC
Critical Dec 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012…
GE Medical Systems China Co., Ltd.
Moderate Dec 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Cepheid
Moderate Dec 24, 2025
Zimmer Dermatome AN, Model/Catalog Number: 88710100
Zimmer Surgical Inc
Moderate Dec 24, 2025
Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 4…
DSAART LLC
Moderate Dec 24, 2025
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube …
Rocket Medical Plc
Moderate Dec 17, 2025
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Medline Industries, LP
Moderate Dec 17, 2025
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Datascope Corp.
Moderate Dec 17, 2025
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the…
Steris Corporation
Moderate Dec 17, 2025
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in th…
Steris Corporation
Moderate Dec 17, 2025
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
C.R. Bard Inc
Low Dec 17, 2025
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x…
Orthofix U.S. LLC
Moderate Dec 17, 2025
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
C.R. Bard Inc
Moderate Dec 17, 2025
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Imm…
Beckman Coulter, Inc.
Moderate Dec 17, 2025
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
Medline Industries, LP
Moderate Dec 17, 2025
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus F…
Cardinal Health 200, LLC
Critical Dec 17, 2025
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the pati…
Draeger, Inc.
Moderate Dec 17, 2025
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Datascope Corp.
Moderate Dec 17, 2025
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
C.R. Bard Inc
Critical Dec 17, 2025
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patie…
Draeger, Inc.
Moderate Dec 17, 2025
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS
Medline Industries, LP
Moderate Dec 17, 2025
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS
Medline Industries, LP
Moderate Dec 17, 2025
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Philips North America
Critical Dec 17, 2025
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient …
Draeger, Inc.
Low Dec 17, 2025
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, …
Orthofix U.S. LLC
Moderate Dec 17, 2025
CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
Medline Industries, LP
Low Dec 17, 2025
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H…
Orthofix U.S. LLC
Moderate Dec 17, 2025
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Bard Peripheral Vascular Inc
Moderate Dec 17, 2025
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
GE Medical Systems, LLC
Moderate Dec 10, 2025
IntelliVue MP90. Product Number: M8010A.
Philips North America Llc
Moderate Dec 10, 2025
Food Intolerance Test Small
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Moderate Dec 10, 2025
IntelliVue MP30. Product Number: M8002A.
Philips North America Llc
Moderate Dec 10, 2025
Vitamin D-Test
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Moderate Dec 10, 2025
Candida Test
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Moderate Dec 10, 2025
Organic Acids Profile Test Large
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Moderate Dec 10, 2025
Allergy Test IgE
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Moderate Dec 10, 2025
Allergy test Small
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Moderate Dec 10, 2025
IntelliVue Patient Monitor MX800. Product Number: 865240.
Philips North America Llc
Moderate Dec 10, 2025
GI Microbiome Profile XL
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Moderate Dec 10, 2025
Illegally Marketed
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Moderate Dec 10, 2025
HPV Antigen Test
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Moderate Dec 10, 2025
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Philips Ultrasound, LLC
Moderate Dec 10, 2025
Sperm Test
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