The Recall Desk

Hazard

Quality Control Failure recalls

163 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
163
Critical
0
Severe
8
Most recent
2026-08-12

Of the 163 quality control failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (5%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all quality control failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

126–150 of 163

  • ModerateFDA (Devices)·Z-0741-2017·2016-12-21

    Cypress Medical Recalls McKesson Vinyl Exam Gloves for Leak Test Failure

    Cypress Medical Products is recalling McKesson Powder Free Vinyl Exam Gloves because a container failed the FDA leak test. The recall is limited to one distribution center in Auburn, Washington.

    Product
    McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2782-2016·2016-09-21

    Trinity Biotech Captia Measles IgM Test Kit Recalled for QC Failure

    Clark Laboratories is recalling specific lots of the Captia Measles IgM test kit because the product failed quality control stability testing.

    Product
    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1046-2016·2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Test Failure

    Sandoz, Inc. is recalling specific lots of Dicloxacillin Sodium Capsules, 500mg, because testing revealed an out-of-specification result for a known impurity.

    Product
    Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2016·2016-04-27

    Abbott Recalls CELL-DYN Emerald Cleaner Due to Analyzer Quality Control Issues

    Abbott Laboratories is recalling CELL-DYN Emerald Cleaner because it may cause the hematology analyzer to generate out-of-range quality control results for RBC and PLT.

    Product
    CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1090-2016·2016-03-16

    TEM Systems Recalls ROTROL P Control for Thromboelastometry System

    TEM Systems Inc is recalling ROTROL P Control quality control material due to customer complaints about failed target ranges for alpha angle.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0371-2016·2015-12-16

    Valeant SPAG-2 6000 Aerosol Generator Recalled for Missing Particle Size Testing

    Valeant Pharmaceuticals is recalling 61 units of the SPAG-2 6000 aerosol generator because they were released without required particle size testing.

    Product
    Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2463-2015·2015-09-02

    Hardy Diagnostics Recalls HardyCHROM MRSA In Vitro Diagnostic Plates

    Hardy Diagnostics is recalling HardyCHROM MRSA plates due to a potential quality control issue involving the MSSA strain.

    Product
    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2071-2015·2015-07-22

    Exactech Single Barrel Drill Guides Recalled for Incomplete Final Inspection

    Exactech, Inc. is recalling two Single Barrel Drill Guides shipped to a single consignee in Florida before final inspection was completed.

    Product
    Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2015·2015-07-15

    Synthes Recalls Three Titanium Tibial Nail End Caps for Missing Inspection

    Synthes is recalling three units of a titanium end cap for tibial nails because they were shipped before a required internal inspection was completed.

    Product
    TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fra
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1947-2015·2015-07-08

    BioMerieux Etest Cefotaxime CT 256 In Vitro Diagnostic Recall

    BioMerieux SA is recalling Etest Cefotaxime CT 256 in vitro diagnostic devices because quality control results were out of range, potentially causing false resistant strain results.

    Product
    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2015·2015-05-20

    Biomerieux Vitek 2 Fungal Susceptibility Cards Recalled for QC Failures

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards due to Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instr
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1130-2015·2015-02-25

    Haemonetics TEG Hemostasis System Level II Control Recall

    Haemonetics is recalling specific lots of TEG Hemostasis System Level II Control kits because they produce high Maximum Amplitude results outside the expected quality control range.

    Product
    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0955-2015·2015-02-04

    GE Healthcare Recalls Revolution CT Scanners Due to Missing Quality Control Test

    GE Healthcare is recalling 13 Revolution CT scanners because a required quality control test was not performed during installation.

    Product
    The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0900-2015·2015-01-07

    Zimmer Recalls Osteobond Bone Cement Due to Adhesive Transfer Defect

    Zimmer, Inc. is recalling 40 units of Osteobond Bone Cement because samples failed to meet visual requirements for adhesive transfer between the Tyvek lid and cavity.

    Product
    Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0006-2015·2014-10-08

    Recall of ENVOY 500 AST Reagent Kits Due to Quality Control Failures

    ELITech Clinical Systems is recalling 878 ENVOY 500 AST Reagent Kits because quality control tests are failing before the products expire.

    Product
    ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1541-2014·2014-08-27

    Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failures

    Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution testing. The recall covers 11,661 bottles distributed nationwide.

    Product
    Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2138-2014·2014-08-13

    Advandx Quick FISH Fixation Kit Recalled for Quality Control Failure

    Advandx Inc is recalling 10 kits of the Quick FISH Fixation Kit for Blood Cultures because they failed internal quality control tests.

    Product
    AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1294-2014·2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling 7,694 bottles of Indomethacin Capsules USP, 25 mg, due to CGMP deviations and laboratory testing failures.

    Product
    INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2014·2014-05-14

    Bio-Rad Variant II beta-thalassemia Short Program kits recalled for buffer issues

    Bio-Rad is recalling Variant II beta-thalassemia Short Program kits because buffer issues may cause calibration and quality control failures.

    Product
    Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separatio
    Category
    Medical Device
    Distribution
    11 states
  • LowFDA (Devices)·Z-1270-2014·2014-04-02

    Lin-Zhi Norbuprenorphine Calibrator Recalled for Quality Control Failure

    Lin-Zhi International is recalling Norbuprenorphine cutoff calibrators because they failed quality control testing. The product is used for in vitro diagnostic calibration.

    Product
    Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1179-2014·2014-03-19

    Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls Due to Concentration Drift

    Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.

    Product
    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liqu
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0943-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Testing Defects

    Ecolab is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0053-2014·2013-10-30

    Alere Triage TOX Drug Screen Control 1 Recalled Due to Code Chip Failure

    Alere San Diego, Inc. is voluntarily recalling Alere Triage TOX Drug Screen Control 1 because a provided code chip causes the control to fail in QC Sample Mode.

    Product
    Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-855-2013·2013-08-14

    Actavis Recalls BuPROPion Hydrochloride Extended-Release Tablets for Dissolution Failure

    Actavis Inc is recalling 15,132 bottles of BuPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg because dissolution test results exceeded approved limits.

    Product
    BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
    Category
    Drug
    Distribution
    Distributed nationwide