Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0974-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0975-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0976-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0977-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0978-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0979-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0980-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0981-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0982-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A
Reason: 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.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0983-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Root cause: Under Investigation by firm
Recalling firm: Microbiologics IncType: Kit, Quality Control For Culture MediaDistribution: Worldwide - US Nationwide.Recall #Z-0984-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Root cause: Under Investigation by firm
Recalling firm: Microbiologics IncType: Kit, Quality Control For Culture MediaDistribution: Worldwide - US Nationwide.Recall #Z-0985-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Root cause: Under Investigation by firm
Recalling firm: Microbiologics IncType: Kit, Quality Control For Culture MediaDistribution: Worldwide - US Nationwide.Recall #Z-0986-2026
Open, ClassifiedPosted Dec 19, 2025·Initiated Nov 20, 2025
BD Pyxis MedStation ES, REF: 323,
BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324,
BD Pyxis MedStation ES Tower, REF: 352,
BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00,
BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00,
BD Pyxis Pro MedStation Main, REF: 1155-00,
BD Pyxis CII Safe ES, REF: 1116-00
Reason: Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
Root cause: Device Design
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - US Nationwide distribution including in the states of CO, IN, OH, TX, KS, FL, GA, NC, CA, HI, IL, NY, MI, VA, AL, LA, NE, KY, OK, AR, TN, WY, NJ, WI, SD, AZ, NV, MO, MA, ID, WV, DE, PA, WA, MT, CT, IA, MD, PR, MN, NM, OR, VT, MS, ME, AK, UT, DC, GU, SC, NH, RI, ND, AS and the countries of CH, CA, KW, QA, NL, GB, UY, AU, NZ, BH, TH, SG, CN, FR, LB, BS, HK, TR, PL, AR, BR, CL, CO, MX, ES, BM, SA, IL.Recall #Z-0962-2026
Open, ClassifiedPosted Dec 19, 2025·Initiated Nov 12, 2025
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation:
Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
Reason: When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
Root cause: Under Investigation by firm
Recalling firm: Howmedica Osteonics Corp.Type: Neurological Stereotaxic InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.Recall #Z-0963-2026
Open, ClassifiedPosted Dec 19, 2025·Initiated Aug 21, 2024
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Reason: Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
Root cause: Device Design
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT.Recall #Z-0964-2026
Open, ClassifiedPosted Dec 19, 2025·Initiated Nov 24, 2025
LifeShield Drug Library Management (DLM);
LifeShield Infusion Safety Software Suite v2.2
List Number 17003-02
Reason: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
Root cause: Software Design Change
Recalling firm: ICU Medical, Inc.Type: Infusion Safety Management SoftwareDistribution: US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.Recall #Z-0965-2026
Open, ClassifiedPosted Dec 19, 2025·Initiated Nov 24, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2
Product No. 17003-02
Reason: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Root cause: Software Design Change
Recalling firm: ICU Medical, Inc.Type: Infusion Safety Management SoftwareDistribution: US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.Recall #Z-0966-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 14, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers:
Carestation 610 A1, REF 1012-9620-222;
Carestation 620 A1 REF 1012-9620-000;
Carestation 620 A1, REF 1012-9620-200;
Carestation 620 A1, REF 1012-9620-202;
Carestation 620 SE A1, REF 1012-9620-212;
Carestation 630 A1, REF 1012-9650-222;
Carestation 650 A1, REF 1012-9650-000;
Carestation 650 A1, REF 1012-9650-200;
Carestation 650 A1, REF 1012-9650-202;
Carestation 650 SE A1, REF 1012-9650-212;
Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine
Products for which affected PMB can be used as a spare part:
Carestation 620 A2, REF 1012-9620-002 00840682124546
Carestation 620 SE A2, REF 1012-9620-012 00195278569677
Carestation 650 A2, REF 1012-9650-002 00840682124560
Carestation 650 SE A2, REF 1012-9650-012 00195278569684
Carestation 650c A1, REF 1012-9655-000 00840682103954
Carestation 650c A2, REF 1012-9655-002 00840682124539
Carestation 650c A1, REF 1012-9655-200 00195278439543
Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.
Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Root cause: Component change control
Recalling firm: GE Medical Systems China Co., Ltd.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 14, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers:
Carestation 750 A1, REF 1012-9750-000;
Carestation 750 A2, REF 1012-9750-002;
Carestation 750c A1, REF 1012-9755-000;
Products for which affected PMB can be used as a spare part:
Carestation 750c A2, REF 1012-9755-002
Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.
Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation,
manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Root cause: Component change control
Recalling firm: GE Medical Systems China Co., Ltd.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.Recall #Z-0914-2026