Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIBD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIBD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIHEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
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.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
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.
- 2025-06-04FDA-DeviceMaquet Cardiopulmonary AgClass IICardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
- 2025-06-04FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
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.
- 2025-06-04FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
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.
- 2025-06-04FDA-DeviceOnkos Surgical, Inc.Class IIELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
- 2025-06-04FDA-DeviceOnkos Surgical, Inc.Class IIELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
- 2025-06-04FDA-DeviceBaxter Healthcare CorporationClass IIAffinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455, P3700E100456, P3700E100457, P3700E100459, P3700E100463, P3700E100468, P3700E100472, P3700E100476, and P3700E100477
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
- 2025-06-04FDA-DeviceBeckman Coulter Ireland, Inc.Class IIIApo B Reagent, REF: OSR6143
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
- 2025-05-28FDA-DeviceAdvanced Bionics, LLCClass IIHiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
- 2025-05-28FDA-DeviceCopan WASPClass IIPhenoMATRIX
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
- 2025-05-28FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIBD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
- 2025-05-28FDA-DeviceEchopixel, Inc.Class IITRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
- 2025-05-28FDA-DeviceSmith & Nephew, Inc.Class IIMETA-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
- 2025-05-28FDA-DevicePhilips North America LlcClass IIProduct Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DevicePhilips North America LlcClass IIProduct Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DevicePhilips North America LlcClass IIProduct Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DevicePhilips North America LlcClass IIProduct Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DevicePhilips North America LlcClass IIProduct Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DevicePhilips North America LlcClass IIProduct Name: Ingenia 3.0T CX; Model Number: 781271;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- 2025-05-28FDA-DevicePhilips North America LlcClass IIProduct Name: Ingenia 1.5T CX; Model Number: 781262;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief