FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 11 of 520
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
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
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
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.
Moderate Nov 26, 2025
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
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.
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
Moderate Nov 26, 2025
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Meridian Bioscience Inc
Moderate Nov 26, 2025
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Medtronic Perfusion Systems
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.
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.
Critical Nov 26, 2025
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
TMJ Solutions Inc
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
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.
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
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.
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.
Moderate Nov 26, 2025
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Medline Industries, LP
Moderate Nov 26, 2025
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Becton Dickinson & Company
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.
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.
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
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.
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
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.
Moderate Nov 26, 2025
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Medline Industries, LP
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
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.
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.
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
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
Moderate Nov 26, 2025
MONARCH Bronchoscope. Model Number: MBR-000211-B
Auris Health, Inc
Moderate Nov 19, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic Perfusion Systems
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
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
Moderate Nov 19, 2025
Radiography 7300 C; Model Number: 712037;
Philips Medical Systems DMC GmbH
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.
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
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
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
Moderate Nov 19, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Covidien, LP
Moderate Nov 19, 2025
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cu…
Medline Industries, LP
Moderate Nov 19, 2025
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
Philips Medical Systems DMC GmbH
Moderate Nov 19, 2025
Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgi…
Medline Industries, LP
Moderate Nov 19, 2025
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical,…
Medline Industries, LP
Moderate Nov 19, 2025
Precision CRF; Model Number: 706400;
Philips Medical Systems DMC GmbH
Moderate Nov 19, 2025
Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgi…
Medline Industries, LP
Critical Nov 19, 2025
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM …
Cerenovus Inc
Critical Nov 19, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Medline Industries, LP
Moderate Nov 19, 2025
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mi…
Philips Respironics, Inc.