January 14, 2026Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and el
Hazard: Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
January 14, 2026Medical DevicesFDA
Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT
Hazard: Potential for incomplete scan due to unstable connection inside of floating sensor.
January 14, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Hazard: Devices are not suitable for organ transplant.
January 14, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Hazard: Devices are not suitable for organ transplant.
January 14, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Hazard: Devices are not suitable for organ transplant.
January 14, 2026Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Hazard: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
January 14, 2026Medical DevicesFDA
Vision RT Ltd recalls The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position
Hazard: Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
January 7, 2026Medical DevicesFDA
Beaver-Visitec International, Inc. recalls BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Hazard: Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
January 7, 2026Medical DevicesFDA
Philips Ultrasound, LLC recalls Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201
Hazard: Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
January 7, 2026Medical DevicesFDA
Sheathing Technologies Inc recalls Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Ster
Hazard: Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
January 7, 2026Medical DevicesFDA
Ferndale Laboratories, Inc. recalls Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description:
Hazard: Butyrate tube cracks during actuation, rendering product unusable.
January 7, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Hazard: Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
January 7, 2026Medical DevicesFDA
SHENZHEN ATOMSTACK TECHNOLOGIES recalls Material Processing Laser Products
Hazard: Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
December 31, 2025Medical DevicesFDA
Beckman Coulter Ireland, Inc. recalls BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitat
Hazard: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
December 31, 2025Medical DevicesFDA
Medtronic Neuromodulation recalls Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90
Hazard: Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
December 31, 2025Medical DevicesFDA
Cook Incorporated recalls R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Ac
Hazard: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
December 31, 2025Medical DevicesFDA
Cook Incorporated recalls Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Trans
Hazard: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
December 31, 2025Medical DevicesFDA
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-4
Hazard: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
December 31, 2025Medical DevicesFDA
Diasol, Inc recalls Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C
Hazard: Safety and efficacy of dialysis acid concentrate cannot be assured
December 31, 2025Medical DevicesFDA
Diasol, Inc recalls Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C
Hazard: Safety and efficacy of dialysis acid concentrate cannot be assured
December 31, 2025Medical DevicesFDA
Diasol, Inc recalls Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C
Hazard: Safety and efficacy of dialysis acid concentrate cannot be assured
December 31, 2025Medical DevicesFDA
Diasol, Inc recalls Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C
Hazard: Safety and efficacy of dialysis acid concentrate cannot be assured
December 31, 2025Medical DevicesFDA
Diasol, Inc recalls Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C
Hazard: Safety and efficacy of dialysis acid concentrate cannot be assured
December 31, 2025Medical DevicesFDA
Diasol, Inc recalls Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C
Hazard: Safety and efficacy of dialysis acid concentrate cannot be assured
December 31, 2025Medical DevicesFDA
Microbiologics Inc recalls LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Hazard: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
December 31, 2025Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Hazard: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
December 31, 2025Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Hazard: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
December 31, 2025Medical DevicesFDA
Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:
Hazard: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
December 31, 2025Medical DevicesFDA
Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:
Hazard: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
December 31, 2025Medical DevicesFDA
Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:
Hazard: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.