Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 11, 2025
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Reason: There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Laparoscopic Bone Anchor Urethropexy Instrument KitDistribution: US Nationwide distribution in the states of AL, AR, AZ, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MT, NC, NJ, OH, OK, PA, SC, TX, VA, WI.Recall #Z-0911-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 27, 2025
Hemodialysis System, Surdial DX
REF: MC+SDX01
Rx Only
Reason: Screw may loosen or fallout of Hemodialysis system
Root cause: Device Design
Recalling firm: Nipro Medical CorporationType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IA, MI, MN, MS, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TX, WV, WC.Recall #Z-0912-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 4, 2025
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Root cause: Component design/selection
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.Recall #Z-0916-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Nov 4, 2025
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Root cause: Component design/selection
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.Recall #Z-0917-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 31, 2025
Stryker MV3 bariatric bed, Part Number 5900000001
Reason: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
Root cause: Release of Material/Component prior to receiving test results
Recalling firm: Stryker Medical Division of Stryker CorporationType: Bariatric BedDistribution: US, nationwideRecall #Z-0918-2026
Open, ClassifiedPosted Dec 11, 2025·Initiated Oct 31, 2025
Stryker Arise 1000EX mattress, Part Number 2236000000
Reason: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
Root cause: Release of Material/Component prior to receiving test results
Recalling firm: Stryker Medical Division of Stryker CorporationType: Mattress, Air Flotation, Alternating PressureDistribution: US, nationwideRecall #Z-0919-2026
Open, ClassifiedPosted Dec 9, 2025·Initiated Oct 27, 2025
Azurion R3.0.
Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Reason: Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm
stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Philips North AmericaType: System, X-Ray, Fluoroscopic, Image-IntensifiedDistribution: U.S.Recall #Z-0597-2026
Open, ClassifiedPosted Dec 9, 2025·Initiated Oct 24, 2025
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Reason: Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).
Root cause: Radiation Control for Health and Safety Act
Recalling firm: GE Medical Systems, LLCType: Full Field Digital, System, X-Ray, MammographicDistribution: U.S. and OUS.Recall #Z-0875-2026
Open, ClassifiedPosted Dec 9, 2025·Initiated Nov 7, 2025
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
Reason: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Root cause: Process design
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: US Nationwide. Global Distribution.Recall #Z-0889-2026
Open, ClassifiedPosted Dec 9, 2025·Initiated Nov 10, 2025
Endo Model Knee Fusion Nail SK, Knee Fusion
Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
Reason: The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Root cause: Process control
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US distribution to states of: AL, GA, and TX.Recall #Z-0890-2026
Open, ClassifiedPosted Dec 8, 2025·Initiated Nov 10, 2025
ErgoStar CM 40
Model/Catalog Number: MP01840
Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Connector, Airway (Extension)Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.Recall #Z-0590-2026
Open, ClassifiedPosted Dec 8, 2025·Initiated Nov 10, 2025
ErgoStar CM 45,
Model/Catalog Number: MP01845,
Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Connector, Airway (Extension)Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.Recall #Z-0591-2026
Open, ClassifiedPosted Dec 8, 2025·Initiated Nov 10, 2025
ErgoStar CM 55,
Model/Catalog Number: MP01855,
Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Connector, Airway (Extension)Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.Recall #Z-0592-2026
Open, ClassifiedPosted Dec 8, 2025·Initiated Nov 10, 2025
ErgoStar CM 60,
Model/Catalog Number: MP01860,
Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Reason: Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Connector, Airway (Extension)Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkiye, Ukraine, and United Kingdom.Recall #Z-0593-2026
Open, ClassifiedPosted Dec 5, 2025·Initiated Oct 27, 2025
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the state of CA.Recall #Z-0886-2026
Open, ClassifiedPosted Dec 5, 2025·Initiated Nov 6, 2025
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Reason: Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Root cause: Process control
Recalling firm: Bard Peripheral Vascular IncType: Thoracentesis TrayDistribution: US Nationwide distribution in the states of CA, MN, IN, MI, LA.Recall #Z-0887-2026
Open, ClassifiedPosted Dec 4, 2025·Initiated Oct 31, 2025
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Reason: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Root cause: Software design
Recalling firm: Philips Ultrasound, LLCType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras , Hungary, Iceland, India, Indonesia, Israel, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam.Recall #Z-0883-2026 Open, ClassifiedPosted Dec 4, 2025·Initiated Oct 28, 2025
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument:
NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098;
NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365;
CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316;
CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316;
CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530;
CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530;
/FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205
Reason: An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
Root cause: Vendor change control
Recalling firm: Illumina, Inc.Type: Reagents For Molecular Diagnostic Test SystemsDistribution: Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT, IL, MD, NY, VA, WV, SD, TX, AL, SC, TN, KY, MI and the countries of DK, SA, FR, DE, IT, CN, PL, GB, TH, GR, VN, BE, ES, IL, KR, AU, CH, BG, NL, IE, TW, TR, CZ, HU, NO, FI, JP, SG, LU, AT, AE, ZA, PT, LT, SE.Recall #Z-0884-2026
Open, ClassifiedPosted Dec 3, 2025·Initiated Nov 3, 2025
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Reason: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Root cause: Process control
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.Recall #Z-0586-2026
Open, ClassifiedPosted Dec 3, 2025·Initiated Oct 24, 2025
MAMMOMAT Revelation;
Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Root cause: Component design/selection
Recalling firm: Siemens Medical Solutions USA, IncType: Full Field Digital, System, X-Ray, MammographicDistribution: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.Recall #Z-0877-2026