Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
PACK GENERAL ROBOTIC. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2259-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2260-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2261-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2262-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 11, 2025
ROBOTIC URO/GYN PACK. Medical convenience kit.
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: Domestic: CA, IL, MD, OH, PA, TX, WA.Recall #Z-2263-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 26, 2025
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Reason: Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
Root cause: Process design
Recalling firm: Beckman Coulter Inc.Type: Ferrozine (Colorimetric) Iron Binding CapacityDistribution: US: AK, AL, AR, CO, CT, DC, DE, ID, UT
OUS: Algeria, Argentina, Australia, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Egypt, El Salvador, Ethiopia, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mexico, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nigeria, North Macedonia, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Province of China, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uzbekistan, Viet Nam, Yemen.Recall #Z-2264-2025
Open, ClassifiedPosted Aug 4, 2025·Initiated Jun 4, 2025
Brand Name: T4 Total ELISA
Product Name: T4 Total ELISA
Model/Catalog Number: EIA-4568
Product Description: T4 Total ELISA
Reason: An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
Root cause: Reprocessing Controls
Recalling firm: DRG International, Inc.Type: Radioimmunoassay, Total ThyroxineDistribution: Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.Recall #Z-2265-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 11, 2025
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade
Ref:
040-02-0110U (Mac 1),
040-02-0120U (Mac 2),
040-02-0130U (Mac 3),
040-02-0131U (Mac 3 Strong Curve)
040-02-0140U (Mac 4),
040-02-0400U (Miller 00),
040-02-0410U (Miller 1),
040-02-0420U (Miller 2),
040-02-0430U (Miller 3),
Reason: Laryngoscope handles may not illuminate as intended.
Root cause: Nonconforming Material/Component
Recalling firm: Flexicare Medical (Dongguan) Ltd.Type: Laryngoscope, RigidDistribution: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.Recall #Z-2182-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 11, 2025
BritePro Solo Single-Use Fiber Optic Handle and Blade
Refs:
040-331U (Mac 1),
040-332U (Mac 2),
040-333U (Mac 3),
040-335U (Mac 3.5)
040-334U (Mac 4),
040-341U (Miller 1),
040-342U (Miller 2),
040-343U (Miller 3),
040-344U (Miller 4),
040-361U (Phillips 1),
040-362U (Phillips 2)
Reason: Laryngoscope handles may not illuminate as intended.
Root cause: Nonconforming Material/Component
Recalling firm: Flexicare Medical (Dongguan) Ltd.Type: Laryngoscope, RigidDistribution: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.Recall #Z-2183-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 11, 2025
BritePro Solo Mini with Pro Miller Blade Size 1.5,
REF:040-02-0415U
Reason: Laryngoscope handles may not illuminate as intended.
Root cause: Nonconforming Material/Component
Recalling firm: Flexicare Medical (Dongguan) Ltd.Type: Laryngoscope, RigidDistribution: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.Recall #Z-2184-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 11, 2025
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle
REF:040-03-0000U
Reason: Laryngoscope handles may not illuminate as intended.
Root cause: Nonconforming Material/Component
Recalling firm: Flexicare Medical (Dongguan) Ltd.Type: Laryngoscope, RigidDistribution: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.Recall #Z-2185-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 11, 2025
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle
REF:040-309U
Reason: Laryngoscope handles may not illuminate as intended.
Root cause: Nonconforming Material/Component
Recalling firm: Flexicare Medical (Dongguan) Ltd.Type: Laryngoscope, RigidDistribution: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.Recall #Z-2186-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 11, 2025
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle
Refs:040-310AU and 040-310U
Reason: Laryngoscope handles may not illuminate as intended.
Root cause: Nonconforming Material/Component
Recalling firm: Flexicare Medical (Dongguan) Ltd.Type: Laryngoscope, RigidDistribution: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.Recall #Z-2187-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Apr 22, 2025
3M Ranger Irrigation Fluid Warming Set, REF 24750
Reason: Notice was issued to clarify flow rates related to the inlet fluid temperature.
Root cause: Device Design
Recalling firm: 3M CompanyType: Warmer, Thermal, Infusion FluidDistribution: US (nationwide) and Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Luxembourg, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.Recall #Z-2231-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jun 24, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Reason: Potential for external cassette leaks
Root cause: Process design
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.Recall #Z-2232-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jun 24, 2025
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Reason: Potential for external cassette leaks
Root cause: Process design
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.Recall #Z-2233-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jun 24, 2025
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Reason: Potential for external cassette leaks
Root cause: Process design
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.Recall #Z-2234-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jun 24, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Reason: Potential for external cassette leaks
Root cause: Process design
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.Recall #Z-2235-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 8, 2025
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Reason: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Root cause: Labeling design
Recalling firm: Becton, Dickinson and Company, BD Bio SciencesType: Counter, Differential CellDistribution: Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.Recall #Z-2237-2025
Open, ClassifiedPosted Aug 1, 2025·Initiated Jul 8, 2025
BD Trucount Controls, 30 Test - REF: 340335
Reason: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Root cause: Labeling design
Recalling firm: Becton, Dickinson and Company, BD Bio SciencesType: Counter, Differential CellDistribution: Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.Recall #Z-2238-2025