The Recall Desk

Hazard

Documentation Issue recalls

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

What the numbers show

Total
135
Critical
0
Severe
0
Most recent
2026-08-26

Of the 135 documentation issue 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.

About this hazard tag

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

1–25 of 135

  • ModerateFDA (Devices)·Z-2750-2026·2026-07-29

    FARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy

    Boston Scientific is recalling 18 FARASTAR Ablation Generator EU devices due to missing FARAPOINT PFA catheter information in the Instructions For Use.

    Product
    FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2751-2026·2026-07-29

    FARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information

    Boston Scientific recalls cardiac ablation generators due to incomplete Instructions For Use that omit information about a compatible catheter.

    Product
    FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1503-2026·2026-03-18

    Penner bathing spa 360030 series recalled for lacking unique device identifier

    Penner Patient Care is recalling Pacific Bathing Spa models in the 360030 series because the device does not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1501-2026·2026-03-18

    Penner Pacific bathing spa 360020-1EP lacks a unique device identifier

    Penner Patient Care is recalling Pacific Bathing Spa model 360020-1EP because the device does not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 360020-1EP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1500-2026·2026-03-18

    Penner bathing spa 360010 series recalled for lacking device identifier

    Penner Patient Care is recalling Pacific Bathing Spa models across the 360010, 362010 and 370000 series because the device does not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1506-2026·2026-03-18

    Penner bathing spa 560010 series recalled for lacking unique device identifier

    Penner Patient Care is recalling Pacific Bathing Spa models in the 560010 series because the device does not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1504-2026·2026-03-18

    Penner bathing spa 361910 series recalled for lacking unique device identifier

    Penner Patient Care is recalling Pacific Bathing Spa models in the 361910 series because the device does not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1499-2026·2026-03-18

    Penner bathing spa 350010 series recalled for lacking unique device identifier

    Penner Patient Care is recalling Pacific Bathing Spa models in the 350010 series because the device does not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1505-2026·2026-03-18

    Penner bathing spa models recalled for lacking a unique device identifier

    Penner Patient Care is recalling Pacific Bathing Spa models 390010-1, 390010-X and 390010-2 because the device does not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1507-2026·2026-03-18

    Penner bathing spa 760010 and 770010 lack unique device identifiers

    Penner Patient Care is recalling Pacific Bathing Spa models 760010-1 and 770010-1 because the device does not bear a unique device identifier.

    Product
    Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0226-2026·2025-10-29

    Sterile blood lancets recalled over incorrect or missing device identifier codes

    Home Health US is recalling 4,661 One Step Sterile Lancets because of incorrect or missing Unique Device Identifier codes.

    Product
    One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-1691-2025·2025-05-07

    Automated External Defibrillators DDU-2200 Missing Italian Language Translation

    Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland because they lack required Italian language labeling and instructions for use.

    Product
    Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0701-2025·2024-12-25

    Augustine HOT DOG Temperature Management Controller Instructions Update

    Augustine Temperature Management is issuing an instructions for use update for its HOT DOG warming controllers (Models WC77, WC77D, WC77R) regarding a power-on self-test error code.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0500-2025·2024-11-27

    Precice Max Orthopedic Implants Recalled for Design and Manufacturing Validation Issues

    NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.

    Product
    Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PREC
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Food)·F-0115-2025·2024-11-13

    MySyrup Sugar Free Madagascar Vanilla Syrup Recalled for Missing Production Records

    My Chai Inc is recalling MySyrup Sugar Free Madagascar Vanilla Syrup nationwide due to missing production records for the acidified product.

    Product
    MySyrup Sugar Free Madagascar Vanilla Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, Madagascar vanilla extract, sodium benzoate and potassium sorbate (to protect flavor), sucralose, acesulfame potassi
    Category
    Food
    Distribution
    Distributed nationwide
  • LowNHTSA·24T007000·2024-06-03

    Hankook Kinergy GT Tires Recalled for Missing Identification Codes

    Hankook is recalling specific Kinergy GT tires because they lack required week and year codes, making it difficult to identify tires involved in future safety recalls.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0475-2024·2023-12-13

    HVAD Ventricular Assist Device Instructions Updated for Alarm Clarification

    Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1423-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-2948-2020·2020-09-16

    MicroPort Recalls PROFEMUR Modular Necks for Package Insert Update

    MicroPort Orthopedics is voluntarily recalling PROFEMUR Titanium and Cobalt Chrome modular necks to replace older package inserts with the most recent revision.

    Product
    PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROM
    Category
    Medical Device
    Distribution
    Distributed nationwide