The Recall Desk

Hazard

Inadequate Testing recalls

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

What the numbers show

Total
8
Critical
0
Severe
1
Most recent
2024-08-14

Of the 8 inadequate testing recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (13%) 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 inadequate testing 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.

1–8 of 8

  • HighFDA (Devices)·Z-2530-2024·2024-08-14

    Baxter SIGMA Spectrum Infusion Pump recall due to inadequate pre-release testing

    Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.

    Product
    Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2024·2024-01-31

    Medtronic Cobalt XT DR MRI cardioverter defibrillator battery testing defect

    Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.

    Product
    Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2022·2022-06-08

    Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.

    Product
    Core Biopsy Tray Catalog Number: 8673R4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Issue

    Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1164-2022·2022-06-08

    Busse Convenience Kits Swabs Recalled Due to Testing Validation Uncertainty

    Busse Hospital Disposables is recalling Busse Convenience Kits containing medical swabs and swabsticks due to uncertainty about test method validation in manufacturing. No illnesses reported.

    Product
    Pain Tray Catalog Number: 9883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1151-2022·2022-06-08

    Busse Hospital Epidural Trays Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Single Shot Epidural Trays due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

    Product
    Single Shot Epidural Tray Catalog 1165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2022·2022-01-12

    Pain Aid ESF Bulk Tablets Recall Due to Manufacturing Process Failures

    ULTRAtab Laboratories is recalling Pain Aid ESF bulk tablets due to failed stability test results and inadequate laboratory investigations, which represent deviations from manufacturing standards.

    Product
    PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0764-2021·2021-06-30

    Designed by Nature Goat's Milk Formula Recalled for Nutrient Deficiencies

    Designed by Nature LLC is recalling its Goat's Milk Formula due to nutrient deficiencies and lack of testing for Cronobacter, a pathogen particularly dangerous to infants. The product was distributed in the US through the firm's website.

    Product
    Designed by Nature Goat's Milk Formula: Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Your Life.
    Category
    Food
    Distribution
    0 states