Open, ClassifiedPosted Jan 8, 2026·Initiated Nov 21, 2025
Medline Hudson RCI Medium Concentration Oxygen Masks:
1041CE
MASK,OXYGEN,UND CHIN,MED CO OUS ONLY;
HUD1035
O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC;
HUD1042
O2 MASK,MED CONC,PEDI,7' TUB SC;
HUD1930
O2 MASK,MED CONC,ADULT,7' TUB UC;
HUDRHO41U
MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC
Reason: Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Mask, OxygenDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.Recall #Z-1035-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 12, 2025
Codman Microsensor Basic Kit. Catalog Number: 626631US.
Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Reason: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Root cause: Process control
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Device, Monitoring, Intracranial PressureDistribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX UT, VA WA and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia (Plurinational State of), Brazil, Canada, Chile, China, Colombia, Cyprus, Czechia, France, Georgia, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Kenya, Korea (the Republic of), Lithuania, Nepal, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).Recall #Z-1036-2026
Open, ClassifiedPosted Jan 8, 2026·Initiated Dec 12, 2025
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850.
The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit.
Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Reason: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Root cause: Process control
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Device, Monitoring, Intracranial PressureDistribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX UT, VA WA and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia (Plurinational State of), Brazil, Canada, Chile, China, Colombia, Cyprus, Czechia, France, Georgia, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Kenya, Korea (the Republic of), Lithuania, Nepal, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).Recall #Z-1037-2026
Open, ClassifiedPosted Jan 7, 2026·Initiated Aug 27, 2025
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Reason: 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).
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Vision RT LtdType: Monitor, Patient Position, Light-BeamDistribution: U.S. and OUSRecall #Z-0998-2026
Open, ClassifiedPosted Jan 6, 2026·Initiated Nov 26, 2025
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Reason: Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Root cause: Device Design
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India
Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of,
Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.Recall #Z-1025-2026
Open, ClassifiedPosted Jan 6, 2026·Initiated Nov 26, 2025
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Reason: Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Root cause: Device Design
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India
Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of,
Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.Recall #Z-1026-2026
Open, ClassifiedPosted Jan 5, 2026·Initiated Dec 5, 2025
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Reason: The affected lots show a decline in performance over time, which may lead to false-negative results.
Root cause: Under Investigation by firm
Recalling firm: Meridian Bioscience IncType: C. Difficile Toxin Gene Amplification AssayDistribution: US Nationwide distribution and the OUS country of Italy.Recall #Z-1019-2026
Open, ClassifiedPosted Jan 2, 2026·Initiated Nov 11, 2025
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Reason: Devices are not suitable for organ transplant.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of FL, GA and Puerto Rico.Recall #Z-1000-2026
Open, ClassifiedPosted Jan 2, 2026·Initiated Nov 11, 2025
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Reason: Devices are not suitable for organ transplant.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of FL, GA and Puerto Rico.Recall #Z-1001-2026
Open, ClassifiedPosted Jan 2, 2026·Initiated Nov 11, 2025
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Reason: Devices are not suitable for organ transplant.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of FL, GA and Puerto Rico.Recall #Z-1002-2026
Open, ClassifiedPosted Jan 2, 2026·Initiated Nov 21, 2025
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Reason: 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.
Root cause: Process control
Recalling firm: Roche Diagnostics Operations, Inc.Type: System, Test, Thyroid AutoantibodyDistribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI, MN, NC, NJ, NM, NY, OH, PA, PR, TN, TX, UT, WA, WV.Recall #Z-1009-2026
Open, ClassifiedPosted Jan 2, 2026·Initiated Dec 11, 2025
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm
REF: CTB23
Reason: There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Root cause: Nonconforming Material/Component
Recalling firm: Applied Medical Resources CorpType: Laparoscope, General & Plastic SurgeryDistribution: US: MI, CA, ME,
OUS: France Great Britain, GermanyRecall #Z-1010-2026
Open, ClassifiedPosted Dec 31, 2025·Initiated Sep 30, 2025
Material Processing Laser Products
Reason: Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Root cause: Radiation Control for Health and Safety Act
Recalling firm: SHENZHEN ATOMSTACK TECHNOLOGIESType: Laser CutterDistribution: U.S.Recall #Z-0888-2026
Open, ClassifiedPosted Dec 31, 2025·Initiated Nov 25, 2025
Brand Name: Mastisol Liquid Adhesive
Product Name: Liquid Adhesive
Model/Catalog Number: 0523-48
Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton
Component: No
Reason: Butyrate tube cracks during actuation, rendering product unusable.
Root cause: Process control
Recalling firm: Ferndale Laboratories, Inc.Type: Tape And Bandage, AdhesiveDistribution: Worldwide distribution - US Nationwide and the country of UK.Recall #Z-1005-2026
Open, ClassifiedPosted Dec 31, 2025·Initiated Nov 17, 2025
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-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Reason: Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Root cause: Process control
Recalling firm: Sheathing Technologies IncType: Transducer, Ultrasonic, DiagnosticDistribution: US Nationwide distribution in the state of WA.Recall #Z-1006-2026 CompletedPosted Dec 31, 2025·Initiated Jul 14, 2022
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer
REF: , , 795200, 795201, 795231, 795232, 795234
REF: 795117, 795122
Reason: Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Root cause: Software Design Change
Recalling firm: Philips Ultrasound, LLCType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of Latvia, Lithuania, Morocco, Netherlands , New Zealand, Oman, Panama, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.Recall #Z-1007-2026 Open, ClassifiedPosted Dec 31, 2025·Initiated Dec 5, 2025
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Reason: 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).
Root cause: Process control
Recalling firm: Beaver-Visitec International, Inc.Type: Laser, OphthalmicDistribution: US Nationwide distribution in the states of FL, MI, OK, TX, WI.Recall #Z-1008-2026
Open, ClassifiedPosted Dec 30, 2025·Initiated Nov 19, 2025
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Reason: Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Root cause: Component design/selection
Recalling firm: Vortex Surgical Inc.Type: Photocoagulator And AccessoriesDistribution: US and JapanRecall #Z-1004-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 24, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Reason: A certain component of affected devices was not delivered within specification and contained impurities.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Vaporizer, Anesthesia, Non-HeatedDistribution: Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, Indonesia, Israel, Japan, Kenya, Mexico, Nepal, Norway, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates, Vietnam.Recall #Z-0933-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 24, 2025
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Reason: A certain component of affected devices was not delivered within specification and contained impurities.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Vaporizer, Anesthesia, Non-HeatedDistribution: Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, Indonesia, Israel, Japan, Kenya, Mexico, Nepal, Norway, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates, Vietnam.Recall #Z-0934-2026