Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL BIOFLO PASV, Catalog Number 60M150373
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class II5F DL BIOFLO PASV, Catalog Number 60M141006
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IITANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL BIOFLO PASV, Catalog Number 60M132324
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL BIOFLO PICC, Catalog Number 60M071831
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS 5F DL XPP, Catalog Number 60M030393
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIRS TANDEM 5F DL XPP, Catalog Number 60M019881
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIMicrointroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIBio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceAngiodynamics Inc. (Navilyst Medical Inc.)Class IIXCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 2018-06-20FDA-DeviceRoche Diabetes Care, Inc.Class IIAccu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus,
The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
- 2018-06-20FDA-DeviceRoche Diabetes Care, Inc.Class IIAccu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
- 2018-06-20FDA-DeviceRoche Diabetes Care, Inc.Class IIAccu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.
- 2018-06-20FDA-DeviceCellavision ABClass IICellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
- 2018-06-20FDA-DeviceZimmer Biomet, Inc.Class IIVanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
- 2018-06-20FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/mL [5.4 ¿mol/L].
- 2018-06-20FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators.
- 2018-06-20FDA-DeviceDatascope CorporationClass IIMaquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up t
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
- 2018-06-20FDA-DeviceDatascope CorporationClass IIMaquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for u
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
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