Medical DeviceMay 16, 2018
Vygon U.S.A PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the recall — FDA Z-1640-2018
Potential friction holes may affect the sterility of the product.
Class IIFDA: TerminatedVygon U.S.A.
Latest records
Latest recalls — page 1440
The newest recall records with useful source details are listed here.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Free Thyroxine (FT4L) Flex reagent cartridge recall — FDA Z-1669-2018
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Vygon U.S.A PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs recall — FDA Z-1637-2018
Potential friction holes may affect the sterility of the product.
Class IIFDA: TerminatedVygon U.S.A.
Medical DeviceMay 16, 2018
Datascope BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966 recall — FDA Z-1732-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Straumann Emdogain 0.3 ml Multipack USA recall — FDA Z-1695-2018
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Class IIFDA: TerminatedStraumann Manufacturing, Inc.
Medical DeviceMay 16, 2018
Datascope ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604 recall — FDA Z-1727-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1557-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Hyphen BioMed ZYMUTEST HIA MonoStria qualitative screening assay intended for the global recall — FDA Z-1743-2018
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Class IIFDA: TerminatedHyphen BioMed
Medical DeviceMay 16, 2018
Datascope BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874 recall — FDA Z-1731-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Aspartate Aminotransferase (AST) assay recall — FDA Z-1651-2018
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Datascope Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504 recall — FDA Z-1708-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic recall — FDA Z-1646-2018
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Datascope BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. recall — FDA Z-1716-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, 28inch large bore tubing recall — FDA Z-1567-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Boston Scientific PFR Kit- Pinnacle, Anterior Apical recall — FDA Z-1624-2018
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Thyroxine (T4) assay recall — FDA Z-1654-2018
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc recall — FDA Z-1675-2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin recall — FDA Z-1681-2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Cook Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The recall — FDA Z-1755-2018
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Class IIFDA: TerminatedCook Inc.
Medical DeviceMay 16, 2018
Mako Surgical RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty recall — FDA Z-1644-2018
Incorrect product and/or label. Sizing is labeled incorrectly.
Class IIFDA: TerminatedMako Surgical Corporation
Medical DeviceMay 16, 2018
Siemens Medical Solutions USA Syngo.plaza software VB10A model numbers: 10863171, 10863172 recall — FDA Z-1699-2018
Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics Dimension Vista Thyroxine (T4) assay recall — FDA Z-1660-2018
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Cook Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The recall — FDA Z-1752-2018
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Class IIFDA: TerminatedCook Inc.
Medical DeviceMay 16, 2018
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No recall — FDA Z-1776-2018
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Class IIFDA: TerminatedTransonic Systems Inc.
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Recent recall archives
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October 2026244 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026371 records · 4 categoriesJune 2026375 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories