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.

26–50 of 163

  • HighFDA (Devices)·Z-1029-2024·2024-02-14

    BD BBL Sensi Disc Doripenem antibiotic susceptibility testing accuracy failures

    BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.

    Product
    BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2024·2024-02-14

    BD BBL Sensi Disc Ceftriaxone Test Discs Recalled for Susceptibility Testing Accuracy Issues

    BD BBL Sensi Disc Ceftriaxone susceptibility test discs may have accuracy and quality control failures. These defects could lead to delayed diagnosis or incorrect antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2024·2024-02-14

    BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.

    Product
    BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2024·2024-02-14

    BD BBL Sensi Disc Ofloxacin discs recalled for antibiotic testing accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1013-2024·2024-02-14

    BD BBL Sensi Disc Ampicillin testing discs recalled for accuracy failures

    Becton Dickinson is recalling 2.3 million antibiotic susceptibility testing discs due to accuracy and quality control failures. The discs may cause delayed or incorrect test results, potentially leading to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2024·2024-02-14

    BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled

    BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.

    Product
    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2024·2024-02-14

    Lab testing discs recalled for potential antibiotic susceptibility testing failures

    Becton Dickinson recalled 2.3 million lab testing discs used for antibiotic susceptibility testing due to potential quality control failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2024·2023-12-06

    Abbott Alinity m HCV Kit Recalled for False Positive Results

    Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.

    Product
    Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in hum
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0326-2024·2023-11-29

    Alinity c Iron Reagent Recalled for Falsely Elevated Test Results

    The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.

    Product
    Alinity c Iron Reagent, Reference Number 08P3920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0106-2024·2023-11-22

    Compressed Oxygen Cylinders Recalled Due to Manufacturing Quality Deviations

    Family Medical Supply Inc is recalling 26,657 cylinders of compressed oxygen distributed nationwide due to manufacturing practice deviations. Cylinders were manufactured between May 10 and October 31, 2023.

    Product
    Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0163-2024·2023-11-01

    Grafton DMB Matrix bone graft recalled for potential outer pouch defects

    Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.

    Product
    Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2075-2023·2023-07-12

    SurgiMend 4.0 Collagen Implants Recalled for Endotoxin Testing Failures

    TEI Biosciences is recalling 5,664 units of SurgiMend 4.0 soft tissue reconstruction implants nationwide due to issues with endotoxin testing that may have resulted in out-of-specification test results.

    Product
    SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2023·2023-07-12

    SurgiMend 2.0 Collagen Matrix Recalled for Endotoxin Testing Issues

    TEI Biosciences is recalling SurgiMend 2.0 collagen matrices nationwide due to possible out-of-specification endotoxin test results from issues with in-process and finished goods testing procedures.

    Product
    SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Worldwide Recall Due to Calibration Failure Potential

    Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.

    Product
    Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0577-2023·2023-05-24

    Ketotifen Fumarate eye drops recalled due to manufacturing quality control deviations

    RemedyRepack Inc. is recalling Ketotifen Fumarate eye drops (NDC 70518-1142-00) distributed in Pennsylvania due to the manufacturer's discontinuation of quality assurance programs, which may have affected product identity, strength, and purity.

    Product
    Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0615-2023·2023-05-24

    Ceftriaxone for Injection Recalled Due to Sterility Assurance Issue

    Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.

    Product
    Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Potential Calibration Failures

    Beckman Coulter has recalled Bicarbonate reagent used in laboratory testing due to a potential decrease in calibration readings. The issue could result in calibration and quality control failures.

    Product
    Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1608-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Calibration Failure Risk

    Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.

    Product
    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0539-2023·2023-04-26

    Antipsychotic Drug Recalled for Failed Quality Control Test

    Ascend Laboratories is recalling 135 bottles of Aripiprazole 20 mg tablets nationwide due to failure of spectroscopic identification testing, indicating the product may not meet established quality standards.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2023·2023-03-15

    Siemens epoc Host 2 blood gas analyzer recalled for pO2 measurement quality control issue

    Siemens is recalling 22,156 units of the epoc Host 2 blood gas analyzer due to pO2 measurement quality control issues related to barometric pressure. The devices are distributed worldwide.

    Product
    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0391-2023·2023-03-08

    Finasteride Tablets 1 mg Recalled for Manufacturing Quality Deviations

    Accord Healthcare recalled 1.4 million bottles of Finasteride 1 mg tablets due to manufacturing quality deviations discovered during FDA inspection. No illnesses have been reported.

    Product
    Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0950-2023·2023-01-18

    IMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues

    Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.

    Product
    IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2023·2023-01-11

    Laboratory quality control material with degraded potency affecting diagnostic verification

    Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.

    Product
    Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2023·2023-01-11

    Randox Protein Control Material Concentration Decreased, Affecting Quality Control

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 3 (catalog PS2684) because the concentration of rheumatoid factor has decreased, causing quality control systems to run outside acceptable ranges and delaying test result reporting.

    Product
    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0350-2023·2022-12-07

    Medical diagnostic control kit recalled for out-of-range quality control results

    Primus Corporation recalls Trinity Biotech HbA1c Control Kits because Control Level I material produces out-of-range results that cause analyzer malfunction and testing delays, potentially delaying patient results.

    Product
    Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
    Category
    Medical Device
    Distribution
    0 states