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.

76–100 of 163

  • ModerateFDA (Devices)·Z-2203-2021·2021-08-11

    In Vitro Diagnostic Reagent Recalled Due to Stability Deterioration

    Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.

    Product
    Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0631-2021·2021-06-23

    Phytonadione Tablets 5 mg Recalled Due to Failed Impurities Specification

    AVKARE Inc. is recalling Phytonadione Tablets 5 mg because the impurity degradant D level failed to meet specification. The affected lot was distributed in Los Angeles, California.

    Product
    Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1373-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-96 plus Reconditioned Instruments

    Beckman Coulter is recalling nine MicroScan WalkAway-96 plus Reconditioned Instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-96 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1370-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-40 plus Instruments

    Beckman Coulter is recalling 16 MicroScan WalkAway-40 plus instruments because a shortened reagent straw may cause reagent dispensing failures, leading to organism misidentification or quality control failures.

    Product
    MicroScan WalkAway-40 plus Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1372-2021·2021-04-14

    Beckman Coulter MicroScan WalkAway-40 Plus Reconditioned Instruments Recalled

    Beckman Coulter is recalling six reconditioned MicroScan WalkAway-40 Plus instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1312-2021·2021-04-07

    LumiraDx Coronavirus Antigen Test Strips Recalled for False Positives

    LumiraDx is recalling 2,186 coronavirus antigen test strips because two lots failed quality control testing and produced false positives.

    Product
    Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2021·2020-12-30

    Beckman Coulter MicroScan Pos MIC Panel Type 34 Recalled for QC Failure

    Beckman Coulter is recalling MicroScan Pos MIC Panel Type 34 because a portion of the lot failed quality control, potentially causing false elevated daptomycin results.

    Product
    MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2020·2020-08-05

    Abbott Alinity ci System Control Module Recalled for Quality Control Failures

    Abbott is recalling Alinity ci System Control Modules because quality control results were not properly evaluated for failures.

    Product
    Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1786-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors during production.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection was used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling 700 temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1783-2020·2020-04-29

    Degania Temperature Sensing Foley Catheters Recalled for Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters due to inadequate incoming inspection practices for the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1782-2020·2020-04-29

    Degania Temperature Sensing Foley Catheters Recalled for Sensor Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors during production.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1787-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling 9,137 temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1461-2020·2020-03-18

    Response Biomedical Recalls RAMP Cardiac Controls Due to Signal Loss

    Response Biomedical Corp. is recalling RAMP Cardiac Controls because CK-MB levels decreased by up to 57% within 11 months, potentially affecting quality control results.

    Product
    Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1334-2020·2020-02-26

    Ethicon Recalls Three Stratafix Suture Units for Internal Testing Failures

    Ethicon, Inc. is recalling three units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.

    Product
    1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1336-2020·2020-02-26

    Ethicon Recalls Stratafix Spiral Sutures for Internal Testing Failures

    Ethicon, Inc. is recalling 133 units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.

    Product
    1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0844-2020·2020-02-26

    Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failure

    The Harvard Drug Group is recalling 246 cartons of Memantine Hydrochloride Extended-Release Capsules, 28mg, due to failed dissolution specifications observed during stability studies.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0153-2020·2019-10-23

    Roche Cobas c Bilirubin Total Gen.3 Recalled for Quality Control Issues

    Roche Diagnostics is recalling 2,304 units of the Cobas c Bilirubin Total Gen.3 in vitro test due to low quality control recovery and invalid calibration.

    Product
    Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0152-2020·2019-10-23

    Roche Diagnostics Recalls cobas Integra Albumin Gen.2 Test Kits

    Roche Diagnostics is recalling cobas Integra Albumin Gen.2 test kits due to low quality control recovery and invalid calibration.

    Product
    Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2019·2019-07-24

    Roche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination

    Roche Diagnostics is recalling Tina-quant lgA Gen.2 assays due to reagent contamination causing calibration and quality control failures.

    Product
    The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
    Category
    Medical Device
    Distribution
    3 states