Open, ClassifiedPosted May 28, 2025·Initiated Mar 31, 2025
Ultrasonic Cleaning Systems
Triton 36 Model Number 6003000804
Triton 72 Model Number 6003000805
Ultrasonic cleaning system
Reason: During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
Root cause: Under Investigation by firm
Recalling firm: Ultra Clean Systems, Inc.Type: Cleaner, Ultrasonic, Medical InstrumentDistribution: Worldwide - U.S. Nationwide distribution including in the states of AZ, CA, CO, FL, ID, IL, IN, KS, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TX, VA, WA, WI, and WY. The country of Canada.Recall #Z-1859-2025
Open, ClassifiedPosted May 28, 2025·Initiated Mar 14, 2025
DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Reason: Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
Root cause: Device Design
Recalling firm: Pro-Med Instruments GmbhType: Holder, Head, Neurosurgical (Skull Clamp)Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, KY, ID, IL, MA, MO, NC, NJ, NY, TX and the countries of Algeria, Argentina, Australia, Austria, Brazil, Burma, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Mexico, Mongolia, Netherlands, Norway, Philippines, Poland, Qatar, Russia, Russia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom.Recall #Z-1860-2025
Open, ClassifiedPosted May 28, 2025·Initiated Apr 14, 2025
Plus Initial Drill, Article Number: 103.170;
Reason: The referred batch was produced without the laser engraving of 7 mm.
Root cause: Under Investigation by firm
Recalling firm: Straumann USA LLCType: Drill, Dental, IntraoralDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MN, NC, NV, NY, OH, OK, SC, TX, VA, WI and the countries of Brazil, Germany, India, Indonesia, Portugal, Romania, Spain, Switzerland, Ukraine.Recall #Z-1861-2025
Open, ClassifiedPosted May 28, 2025·Initiated May 1, 2025
GM Helix Acqua Implant, Article Number: 140.984
Reason: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Root cause: Under Investigation by firm
Recalling firm: Straumann USA LLCType: Implant, Endosseous, Root-FormDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.Recall #Z-1862-2025
Open, ClassifiedPosted May 28, 2025·Initiated May 1, 2025
GM Helix Acqua Implant, Article Number: 140.985
Reason: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Root cause: Under Investigation by firm
Recalling firm: Straumann USA LLCType: Implant, Endosseous, Root-FormDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.Recall #Z-1863-2025
Open, ClassifiedPosted May 28, 2025·Initiated Apr 28, 2025
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Reason: Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
Root cause: Under Investigation by firm
Recalling firm: NxStage Medical IncType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: US Nationwide distribution.Recall #Z-1864-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 15, 2025
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Reason: Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Calibrator, PrimaryDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, VT, WI, WY and the countries of Austria, Belgium, Croatia, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lithuania, Nepal, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Vatikan City, Zaire.Recall #Z-1821-2025 Open, ClassifiedPosted May 27, 2025·Initiated Apr 15, 2025
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Reason: Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Calibrator, PrimaryDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, VT, WI, WY and the countries of Austria, Belgium, Croatia, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lithuania, Nepal, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Vatikan City, Zaire.Recall #Z-1822-2025 Open, ClassifiedPosted May 27, 2025·Initiated Apr 30, 2025
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Reason: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Root cause: Under Investigation by firm
Recalling firm: Maquet Cardiopulmonary AgType: Console, Heart-Lung Machine, Cardiopulmonary BypassDistribution: Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, South Korea, Poland, Russia, Saudi Arabia, Spain, Switzerland, Thailand.Recall #Z-1823-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Multi-Analyte Controls, All Kinds (Assayed)Distribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1824-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Colorimetric Method, TriglyceridesDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1825-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Colorimetric Method, TriglyceridesDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1826-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Glucose Oxidase, GlucoseDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1827-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Culture Media, Non-Selective And Non-DifferentialDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1828-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Culture Media, Selective And DifferentialDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1829-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Assay, Glycosylated HemoglobinDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1830-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Azo Dye, CalciumDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1831-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Phosphomolybdate (Colorimetric), Inorganic PhosphorusDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1832-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Radioimmunoassay, VancomycinDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1833-2025
Open, ClassifiedPosted May 27, 2025·Initiated Apr 24, 2025
ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Root cause: Storage
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: General Purpose ReagentDistribution: US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.Recall #Z-1834-2025