The Recall Desk

Hazard

Validation Failure recalls

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

What the numbers show

Total
19
Critical
0
Severe
0
Most recent
2024-03-20

Of the 19 validation 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 0 (0%) 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 validation 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.

1–19 of 19

  • HighFDA (Devices)·Z-1290-2024·2024-03-20

    CARTO VIZIGO Guiding Sheath Recalled for Manufacturing Validation Issue

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.

    Product
    CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1133-2023·2023-09-06

    Injectable Oxytocin Recalled Due to Unvalidated Sterilization Process

    Central Admixture Pharmacy Services recalls oxytocin IV bags due to inadequate validation of sterilization, raising sterility concerns for this injectable.

    Product
    oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1076-2023·2023-08-09

    Rocuronium Syringes Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling rocuronium syringes due to lack of validation data for sanitization cycles, which cannot assure sterility. The recall affects 10,065 syringes distributed nationwide.

    Product
    rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0992-2023·2023-08-09

    Neonatal TPN Starter Bag Recall Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags because sterility cannot be assured and decontamination cycle validation data is lacking. The affected lot (36-254911) was distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1015-2023·2023-08-09

    Cardioplegia Solution IV Bags Recalled for Sterility Assurance Deficiency

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution IV bags (Lot 36-257024) due to lack of sterility assurance and insufficient validation of decontamination processes. Healthcare providers should discontinue use immediately.

    Product
    CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0216-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1011-2023·2023-08-09

    Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 420 neonatal TPN starter bags due to lack of sterility assurance and validation data for decontamination cycles. The recalled lots were distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1057-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled Due to Unvalidated Sanitization Cycles

    Central Admixture Pharmacy is recalling HYDROmorphone injection syringes nationwide due to lack of validated sanitization cycles, which compromises sterility.

    Product
    HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2022·2022-10-05

    SporView Sterilization Biological Indicator Kit Recalled for Temperature Exposure

    McKesson is recalling SporView Culture Set biological indicator kits (models CS-020 and CS-100) due to facility temperature excursions that may have compromised product effectiveness. Affected units were distributed nationwide between June and September 2021.

    Product
    a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2022·2022-09-14

    Pacemaker and Cardiothoracic Surgical Packs Recalled for Improper Sterilization Validation

    American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.

    Product
    Various Pacemaker Packs, Cardio Thoracic Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1188-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2022·2022-06-08

    Busse Nerve Block Tray Swabs Recalled for Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.

    Product
    Nerve Block Tray Catalog Number: 3764R2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2022·2022-06-08

    Sterile Epidural Tray Recalled Due to Validation Uncertainty

    Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.

    Product
    Sterile Epidural Tray Catalog Number: 6259R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2022·2022-06-08

    I.V. Start Kit Recall Due to Uncertain Manufacturing Process Validation

    Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.

    Product
    I.V. Start Kit Catalog 8172
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2022·2022-06-08

    Epidural Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.

    Product
    Single Shot Epidural Tray Catalog Number: 6183R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2022·2022-06-08

    Swab and Swabstick Drug Products Recalled Due to Validation Uncertainty

    Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.

    Product
    "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1181-2022·2022-06-08

    Medical swab insertion tray recalled due to manufacturing validation uncertainty

    Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.

    Product
    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1177-2022·2022-06-08

    Busse Convenience Kits with Swabs Recalled Due to Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products are recalled due to uncertainty about whether test methods used to validate manufacturing were adequately validated. Distributed nationwide.

    Product
    Bone Marrow Biopsy Tray Catalog Number: 8917R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2022·2022-05-04

    IV Start Kit Convenience Kits Recalled for Inadequate Test Method Validation

    ROi CPS LLC is recalling 1,501 convenience kits containing regard IV Start Kits due to inadequate validation of manufacturing test methods. Products were distributed in Missouri.

    Product
    Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1496-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Validation Concerns

    Diagnostic Hybrids, Inc. is recalling 101 MicroVue CIC-C1q EIA kits because the standard curve slope may fail validation requirements.

    Product
    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the dilut
    Category
    Medical Device
    Distribution
    4 states