The Recall Desk

Hazard

Quality System Deficiency recalls

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

What the numbers show

Total
14
Critical
0
Severe
2
Most recent
2026-05-13

Of the 14 quality system deficiency recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (14%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all quality system deficiency 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.

1–14 of 14

  • SevereFDA (Drugs)·D-0519-2026·2026-05-13

    Octreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance

    Teva Pharmaceuticals USA, Inc. is recalling 2,200 kits of Octreotide Acetate for Injectable Suspension (30 mg) due to quality system deficiencies that affect sterility assurance. The recall affects all lots nationwide.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0406-2026·2026-04-01

    Teva octreotide acetate injection recalled over sterility assurance deficiencies

    Teva is recalling twelve lots of Octreotide Acetate for Injectable Suspension after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0404-2026·2026-04-01

    Teva octreotide acetate 10 mg recalled over sterility assurance deficiencies

    Teva is recalling two lots of Octreotide Acetate for Injectable Suspension 10 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0405-2026·2026-04-01

    Teva octreotide acetate 20 mg recalled over sterility assurance deficiencies

    Teva is recalling nine lots of Octreotide Acetate for Injectable Suspension 20 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0058-2024·2023-11-01

    FDA Recalls Ovulation Test Strips for Unverified Manufacturing and Documentation

    FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.

    Product
    DiagnosUS One Step LH Ovulation Test Strip REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0782-2017·2016-12-28

    FDA Recalls Ultroid Hemorrhoid Management Systems for Quality System Deficiencies

    The FDA is recalling Ultroid Hemorrhoid Management Systems because they were not manufactured under required quality system controls.

    Product
    Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2245-2015·2015-08-05

    EXP Pharmaceutical Services Recalls TAUT Intraducer Peritoneal Catheters

    EXP Pharmaceutical Services Corp is recalling TAUT Intraducer Peritoneal Catheters because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2236-2015·2015-08-05

    EXP Recalls Unregistered Orthopedic Saw Blades Due to Regulatory Non-Compliance

    EXP Pharmaceutical Services Corp is recalling two sterile orthopedic saw blades because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2237-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Sterile Nonabsorbable Sutures and Sternotomy Wires

    EXP Pharmaceutical Services Corp is recalling 19 units of sterile nonabsorbable sutures and sternotomy wires due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2249-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Airway Stent Systems

    EXP Pharmaceutical Services Corp is recalling 10x40 Airway Stent Systems because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2250-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Angio-Seal Vascular Closure Devices

    EXP Pharmaceutical Services Corp is recalling three Angio-Seal VIP Platform vascular closure devices due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2230-2015·2015-08-05

    EXP Recalls Fiberwire Suture Scissors Due to Registration Violations

    EXP Pharmaceutical Services Corp is recalling Fiberwire Suture Scissors because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-0531-2014·2014-01-01

    C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies

    C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.

    Product
    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2012·2012-08-15

    Tango3 Water Storage Tank Recalled for Quality System Deficiencies

    Tango3 LLC is recalling 44 water storage tanks with ozone disinfection systems due to quality system deficiencies and lack of assurance that systems operate at minimum ozone levels.

    Product
    TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water dis
    Category
    Medical Device
    Distribution
    23 states