FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 13 of 520
Moderate Nov 5, 2025
9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
ICU Medical, Inc.
Critical Nov 5, 2025
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
IMPRIS Imaging Inc
Moderate Nov 5, 2025
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
ICU Medical, Inc.
Moderate Nov 5, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…
Alcon Research LLC
Moderate Nov 5, 2025
BD Pyxis Pro MedStation Main, REF: 1155-00
CareFusion 303, Inc.
Moderate Nov 5, 2025
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile,…
ENDOMAGNETICS LTD
Moderate Nov 5, 2025
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
ICU Medical, Inc.
Moderate Nov 5, 2025
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Canon Medical System, USA, INC.
Moderate Nov 5, 2025
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
ICU Medical, Inc.
Moderate Nov 5, 2025
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
ICU Medical, Inc.
Moderate Nov 5, 2025
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Surgical Theater Inc
Moderate Nov 5, 2025
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Theater Inc
Moderate Nov 5, 2025
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
PHILIPS MEDICAL SYSTEMS
Moderate Nov 5, 2025
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. The…
Beckman Coulter, Inc.
Moderate Nov 5, 2025
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Descriptio…
Aesculap Inc
Moderate Nov 5, 2025
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Trividia Health, Inc.
Moderate Nov 5, 2025
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
ICU Medical, Inc.
Moderate Nov 5, 2025
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
Surgical Theater Inc
Moderate Nov 5, 2025
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
ICU Medical, Inc.
Moderate Nov 5, 2025
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Theater Inc
Moderate Nov 5, 2025
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDU…
Aesculap Inc
Moderate Nov 5, 2025
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Versio…
Medistim Asa
Moderate Nov 5, 2025
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
ICU Medical, Inc.
Moderate Nov 5, 2025
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01…
CareFusion 303, Inc.
Moderate Nov 5, 2025
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collec…
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Critical Nov 5, 2025
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT0911…
BALT USA, LLC
Moderate Nov 5, 2025
ICU Medical ChemoLock Port REF: CL2100
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated…
ICU Medical, Inc.
Moderate Nov 5, 2025
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
ICU Medical, Inc.
Moderate Nov 5, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…
Alcon Research LLC
Moderate Nov 5, 2025
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
ICU Medical, Inc.
Moderate Nov 5, 2025
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer R…
ICU Medical, Inc.
Moderate Nov 5, 2025
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
PHILIPS MEDICAL SYSTEMS
Moderate Nov 5, 2025
ICU Medical ChemoLock Bag Spike REF: CL-10
ICU Medical, Inc.
Moderate Nov 5, 2025
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
DAYE (ANNE'S DAY LTD)
Moderate Nov 5, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…
Alcon Research LLC