PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 11 of 548

FDA Devices Critical Nov 26, 2025

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with …

CareFusion 303, Inc.

FDA Devices Moderate Nov 26, 2025

Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, Hear…

Thoratec LLC

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A cle…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Descript…

Exactech, Inc.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Meridian Bioscience Inc

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 …

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

Medtronic Perfusion Systems

FDA Devices Low Nov 26, 2025

OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

FDA Devices Moderate Nov 26, 2025

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model…

Olympus Corporation of the Americas

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, p…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: Th…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Meridian Bioscience Inc

FDA Devices Moderate Nov 26, 2025

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

Medtronic Perfusion Systems

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood colle…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blo…

Greiner Bio-One North America, Inc.

FDA Devices Critical Nov 26, 2025

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

TMJ Solutions Inc

FDA Devices Moderate Nov 26, 2025

Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762…

Thoratec LLC

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The S…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; …

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description:…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A …

Quest International, Inc.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

Becton Dickinson & Company

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product D…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voi…

Berkeley Advanced Biomaterials, LLC

FDA Devices Moderate Nov 26, 2025

DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic d…

Beckman Coulter Inc.

FDA Devices Moderate Nov 26, 2025

Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Se…

Thoratec LLC

FDA Devices Moderate Nov 26, 2025

Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8F…

Sterilmed, Inc.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Pr…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear,…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL V…

Medline Industries, LP

CPSC Moderate Nov 26, 2025

McLee Creations Recalls MyOnlyStyler Root Booster Hair Dryers Due to Risk of Serious Injury or Death from Electrocution and Shock Hazards

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK C…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

MONARCH Bronchoscope. Model Number: MBR-000211-B

Auris Health, Inc

FDA Devices Moderate Nov 19, 2025

Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

Medtronic Perfusion Systems

FDA Devices Moderate Nov 19, 2025

Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I

Applied Medical Technology Inc

FDA Devices Moderate Nov 19, 2025

Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPul…

Olympus Corporation of the Americas

FDA Devices Moderate Nov 19, 2025

Radiography 7300 C; Model Number: 712037;

Philips Medical Systems DMC GmbH

FDA Devices Moderate Nov 19, 2025

Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision …

TECHNO-PATH MANUFACTURING LTD.

FDA Devices Moderate Nov 19, 2025

B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 61600…

GE Healthcare Finland Oy

FDA Devices Moderate Nov 19, 2025

CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physio…

GE Healthcare Finland Oy

FDA Devices Moderate Nov 19, 2025

Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, C…

Medline Industries, LP

FDA Devices Moderate Nov 19, 2025

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;

Covidien, LP