Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-11-24FDA-DeviceROi CPS LLCClass IIREGARD Stereotactic Tray
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
- 2021-11-24FDA-DeviceROi CPS LLCClass IIREGARD Newborn Tray
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
- 2021-11-24FDA-DeviceROi CPS LLCClass IIREGARD Ear Tray
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
- 2021-11-24FDA-DeviceROi CPS LLCClass IIREGARD Core Biopsy Tray
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
- 2021-11-24FDA-DeviceROi CPS LLCClass IIREGARD Basic Cataract tray
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
- 2021-11-24FDA-DeviceFujifilm Irvine Scientific, Inc.Class IIVit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocyte
Due to a component in kit being labeled with the incorrect Expiration Date
- 2021-11-24FDA-DeviceFujifilm Irvine Scientific, Inc.Class IIVit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocyte
Due to a component in kit being labeled with the incorrect Expiration Date
- 2021-11-24FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIIVITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
- 2021-11-24FDA-DeviceMedicalplastic S.R.L.Class IIIlizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.
- 2021-11-24FDA-DeviceLaboratoires Bodycad, Inc.Class IITorque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.
- 2021-11-24FDA-DevicebioMerieux, Inc.Class IIAPI 50 CH, Model 50300
There is potential to provide an incorrect organism identification.
- 2021-11-24FDA-DeviceOmniLife ScienceClass IIOMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
- 2021-11-24FDA-DeviceBio-Rad Laboratories, Inc.Class IIBIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
- 2021-11-24FDA-DeviceBio-Rad Laboratories, Inc.Class IIBIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
- 2021-11-24FDA-DeviceArrow International IncClass IArrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- 2021-11-24FDA-DeviceArrow International IncClass IArrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- 2021-11-24FDA-DeviceArrow International IncClass IArrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- 2021-11-24FDA-DeviceArrow International IncClass IArrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
- 2021-11-24FDA-DeviceBeaver Visitec International, Inc.Class IIbvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
- 2021-11-24FDA-DeviceBeaver Visitec International, Inc.Class IIbvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
- 2021-11-24FDA-DeviceBeaver Visitec International, Inc.Class IIbvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
- 2021-11-24FDA-DeviceBeaver Visitec International, Inc.Class IIBeaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
- 2021-11-24FDA-DeviceSiemens Medical Solutions USA, IncClass IISensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
- 2021-11-24FDA-DeviceScrip IncClass IScrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- 2021-11-24FDA-DeviceScrip IncClass IScrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- 2021-11-24FDA-DeviceCook Inc.Class IITransseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
- 2021-11-24FDA-DeviceCook Inc.Class IITransseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
- 2021-11-24FDA-DeviceCordis CorporationClass IISMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
- 2021-11-24FDA-DeviceCordis CorporationClass IISMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
- 2021-11-24FDA-DeviceCordis CorporationClass IISMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
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