The Recall Desk

Hazard

Documentation Gap recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2025-07-23

Of the 5 documentation gap 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 documentation gap 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.

1–5 of 5

  • ModerateFDA (Drugs)·D-0530-2025·2025-07-23

    Compounded parenteral nutrition bags recalled over insufficiently documented cleaning step

    Two bags of compounded Peripheral Parenteral Nutrition are being recalled because a daily cleaning step in the ISO-5 compounding area was not sufficiently documented.

    Product
    PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0049-2024·2023-11-01

    Pregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure

    Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.

    Product
    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0898-2023·2023-07-19

    Eye drops Equate and private-label brands recalled for manufacturing documentation deficiency

    K.C. Pharmaceuticals is recalling 397,430 bottles of Equate and private-label dry eye relief drops nationwide due to Current Good Manufacturing Practice deficiencies related to fill line documentation.

    Product
    EQUATE EYE DROPS DRY EYE RELIEF — EQUATE EYE DROPS DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2021·2021-03-03

    Siemens ARTIS Icono Biplane and Floor Systems Recalled for Software Errors

    Siemens is recalling 41 ARTIS Icono systems with software version VE20B due to misleading error messages and manual gaps that may cause procedure termination.

    Product
    ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2012·2012-08-15

    Oklahoma Respiratory Care Recalls Compressed Oxygen Cylinders for Testing Failures

    Oklahoma Respiratory Care Inc is recalling 861 cylinders of compressed oxygen due to missing identity and purity testing and documentation gaps.

    Product
    OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
    Category
    Drug
    Distribution
    1 state