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.

151–163 of 163

  • ModerateFDA (Drugs)·D-802-2013·2013-07-24

    Quetiapine Fumarate Tablets Recalled for Failed Dissolution Test

    American Health Packaging is recalling Quetiapine Fumarate 25mg tablets because they failed a dissolution test during stability studies.

    Product
    QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-632-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Acetylcysteine 10% Solution

    Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 10% Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-370-2013·2013-05-22

    Green Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns

    Green Valley Drugs is recalling Human Chorionic Gonadotropin (HCG) injections due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1280-2013·2013-05-22

    AMS 800 Urinary Control System Components Recalled for Release Criteria Failures

    American Medical Systems is recalling 77 AMS 800 Control Pumps and Pressure-Regulating Balloons because they were released without meeting final product release criteria.

    Product
    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2013·2013-05-22

    American Medical Systems Recalls AMS 800 Urinary Control System Components

    American Medical Systems is recalling 605 AMS 800 Urinary Control System pumps and balloons released without meeting final product criteria.

    Product
    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2013·2013-04-24

    Bacterin OsteoSelect DBM Putty Recalled for Unvalidated Testing Procedure

    Bacterin International is recalling 165 units of OsteoSelect DBM Putty because the firm's retesting procedure was not validated.

    Product
    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2013·2013-03-06

    Philips CT Systems Recalled for Deteriorating Image Quality Phantom Pins

    Philips Medical Systems is recalling 1,474 CT scanners because low-contrast pins in the Image Quality phantom deteriorate, preventing required daily checks.

    Product
    Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0641-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Failure

    Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2013·2012-11-07

    Siemens ADVIA Centaur BR Assay Recalled for Quality Control Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR Assay kits because quality control results fell outside expected ranges.

    Product
    Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2352-2012·2012-09-26

    Custom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues

    Custom Medical Specialties is recalling CMS-8450-R1 Custom Vein Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.

    Product
    CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2353-2012·2012-09-26

    Custom Medical Specialties Recalls Amnio Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CMS-2586 Custom Amnio Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet finished goods specifications.

    Product
    CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2012·2012-09-12

    Siemens syngo Lab Data Manager Recall for Quality Control Defect

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager and Process Manager software due to a defect that may prevent the system from flagging quality control violations appropriately.

    Product
    syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple inter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2012·2012-08-29

    Siemens EasyLink Informatic System Recalled for Quality Control Defect

    Siemens Healthcare Diagnostics is recalling 637 EasyLink Informatic Systems because they may fail to flag quality control violations, potentially affecting patient result verification.

    Product
    EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine
    Category
    Medical Device
    Distribution
    Distributed nationwide