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-DeviceNxStage Medical IncClass IINxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
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.
- 2025-06-04FDA-DeviceStraumann USA LLCClass IIGM Helix Acqua Implant, Article Number: 140.985
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- 2025-06-04FDA-DeviceStraumann USA LLCClass IIGM Helix Acqua Implant, Article Number: 140.984
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- 2025-06-04FDA-DeviceStraumann USA LLCClass IIPlus Initial Drill, Article Number: 103.170;
The referred batch was produced without the laser engraving of 7 mm.
- 2025-06-04FDA-DevicePro-Med Instruments GmbhClass IIDORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
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.
- 2025-06-04FDA-DeviceUltra Clean Systems, Inc.Class IIUltrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
- 2025-06-04FDA-DeviceC-RAD POSITIONING ABClass IIBrand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
- 2025-06-04FDA-DeviceOnkos Surgical, Inc.Class IIELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
- 2025-06-04FDA-DevicePrismatik Dentalcraft, Inc.Class IIGlidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
- 2025-06-04FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIHEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL 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 IISEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
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 DIAGNOSTICS ALINITY I ANTI-CCPS 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 DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) 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 DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) 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 DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
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 DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
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 DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
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 DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS 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 POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
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 DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
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 DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA 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 DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B 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 DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) 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 DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
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 DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
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 HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE 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-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIHEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE 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-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (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 ANTI-B BIOCLONE 10ML3X10ML.
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 TOTAL BILI-ALKP XT (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.
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