DrugApr 22, 2020
Filltech USA Dermatone recall — FDA D-1242-2020
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class IIFDA: TerminatedFilltech USA, LLC
Latest records
Latest recalls — page 1041
The newest recall records with useful source details are listed here.
DrugApr 22, 2020
Golden State Medical Supply Losartan Potassium Tablets, USP, 25 mg recall — FDA D-1238-2020
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Class IIFDA: TerminatedGolden State Medical Supply Inc.
VehicleApr 20, 2020
Driverge retractor recall — NHTSA campaign 20V222000
TransitWorks is recalling certain Driverge vehicles based on 2019-2020 Ford Transit vans equipped with Freedman Seating Company (FSC) PT Foldaway and GO-ES 3-point Foldaway seats. The seat…
retractorTransitWorks
VehicleApr 16, 2020
Subaru of fuel pump recall — NHTSA campaign 20V218000
Subaru of America, Inc. (Subaru) is recalling certain 2019 Impreza, Outback, Legacy, and Ascent vehicles. The low pressure fuel pump may become inoperative.
fuel pumpSubaru of America, Inc.
Medical DeviceApr 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM recall — FDA Z-1648-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
Siemens Medical Solutions USA PRIMUS HI #04504200 with Digital LINAC Systems Control Console recall — FDA Z-1680-2020
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceApr 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175 recall — FDA Z-1668-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184 recall — FDA Z-1641-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
Siemens Medical Solutions USA ARTISTE MV System Model #8139789 with Digital LINAC Systems recall — FDA Z-1677-2020
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceApr 15, 2020
Baxter Healthcare GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended recall — FDA Z-1685-2020
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceApr 15, 2020
James Leckey Design Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat recall — FDA Z-1683-2020
The firm received reports of a number of broken latches on the floorsitter.
Class IIFDA: OngoingJames Leckey Design Ltd
Medical DeviceApr 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160 recall — FDA Z-1662-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone recall — FDA Z-1653-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI recall — FDA Z-1670-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM recall — FDA Z-1644-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
Synvasive Technology ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x recall — FDA Z-1676-2020
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Class IIFDA: TerminatedSynvasive Technology Inc.
Medical DeviceApr 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM recall — FDA Z-1645-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
Microbiologics KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 recall — FDA Z-1690-2020
KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida…
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceApr 15, 2020
Zeiss, Carl Component for Laser Scanning Microscopes recall — FDA Z-1629-2020
When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue…
Class IIFDA: TerminatedZeiss, Carl Inc.
Medical DeviceApr 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165 recall — FDA Z-1666-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
Abbott Laboratories "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 recall — FDA Z-1688-2020
Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of…
Class IIFDA: TerminatedAbbott Laboratories
Medical DeviceApr 15, 2020
Radiometer Medical ApS ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of recall — FDA Z-1684-2020
Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This…
Class IIFDA: TerminatedRadiometer Medical ApS
Medical DeviceApr 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone recall — FDA Z-1654-2020
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 15, 2020
Qualigen The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative recall — FDA Z-1672-2020
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human…
Class IIFDA: TerminatedQualigen Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026180 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 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