The Recall Desk

Hazard

Documentation Deficiency recalls

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

What the numbers show

Total
66
Critical
0
Severe
0
Most recent
2024-11-13

Of the 66 documentation 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 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 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.

51–66 of 66

  • ModerateFDA (Devices)·Z-2850-2017·2017-08-16

    International Medsurg Piston Syringes Recalled for Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of dise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2824-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2843-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because of insufficient documentation to support sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2017·2017-06-14

    Cook Medical Recalls Endoscopic Curved Needles Due to Reprocessing Instruction Deficiencies

    Cook Medical is voluntarily recalling 725 units of endoscopic curved needles because the reprocessing instructions do not provide sufficient detail for proper cleaning and sterilization.

    Product
    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of stand
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0039-2017·2016-10-19

    Schafer Fisheries Recalls Fish Hot Dogs Due to HACCP Record Deficiencies

    Schafer Fisheries is recalling specific lots of fish hot dogs because of inadequate HACCP records. The products were distributed in Illinois, New York, and California.

    Product
    *** 1) Fish hot dogs total 1 lb in weight vacuum packaged in plastic bags; Label reads in part: TWIN FIN DELI; Franks; Net WT. 1lb (453g); Kosher Fish Products Inc. Fulton, IL FDA# 1481764; *** 2) Fish hot dogs total 15 lbs in weight packaged 120 x box with a poly liner
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0041-2017·2016-10-19

    Schafer Fisheries Recalls Gefilte Fish Due to HACCP Record Deficiencies

    Schafer Fisheries is recalling 250 cases of Twin Fin Deli Gefilte Fish because the company lacked adequate HACCP records. The product was distributed in Illinois, New York, and California.

    Product
    Label reads in part: TWIN FIN DELI; Gefilte Fish; Kosher Fish Products Inc., Fulton, IL. FDA# 1481764; Net WT. 24 OZ (680G)
    Category
    Food
    Distribution
    3 states
  • LowFDA (Devices)·Z-0129-2016·2015-11-18

    Villa Radiology Systems Recalls Owandy I-MAX Touch 3D X-ray Units

    Villa Radiology Systems LLC is recalling six Owandy Radiology I-MAX Touch 3D X-ray units because they lack required accompanying information documents.

    Product
    Owandy Radiology I -MAX Touch 3D X-ray
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1298-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine and Phentermine Injection for Sterility Concerns

    The Apothecary Shoppe LLC is recalling specific vials of Papaverine and Phentermine Injection due to a lack of documentation proving proper environmental monitoring during production.

    Product
    SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2183-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1632-2014·2014-05-28

    SCM True Air Technologies Recalls MaXair Mattress Replacement Systems

    SCM True Air Technologies is recalling 83 MaXair True Low Air Loss Mattress Replacement Systems due to design control and documentation deficiencies.

    Product
    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0764-2013·2013-02-06

    MOOG Infinity Enteralite Feeding Pumps Recall for Manual Addendum

    MOOG Medical Devices Group is recalling 92,488 Infinity Enteralite Ambulatory Feeding Pumps to add an operator's manual addendum regarding the Infinite Dose mode and air-in-line detection limitations.

    Product
    Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0334-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Gaps

    Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly dose sterility audits were performed.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2012·2012-09-26

    RaySearch TomoTherapy SharePlan Software Field Notice for Unexpected Behaviors

    RaySearch Laboratories issued a field notice for TomoTherapy SharePlan software due to two unexpected behaviors not clearly described in the user manual. No patient mistreatment or incidents have occurred.

    Product
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-
    Category
    Medical Device
    Distribution
    6 states