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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 3441–3460 of 39,430 recalls

Class IIOngoing

ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IOngoing

Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS

Baxter Healthcare Corporation

There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.

Mckesson Medical-Surgical Inc. Corporate Office

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.

April 24, 2025 · DeviceView details →
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