The Recall Desk

Hazard

Missing Documentation recalls

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

What the numbers show

Total
26
Critical
0
Severe
1
Most recent
2025-10-15

Of the 26 missing documentation 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 (4%) 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 missing documentation 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 26

  • ModerateFDA (Devices)·Z-0072-2026·2025-10-15

    Collagen vascular grafts recalled over incorrect labels missing CE and UKCA marks

    LeMaitre Vascular is recalling 10 Artegraft Collagen Vascular Grafts distributed with an incorrect label lacking CE and UKCA marks and without the patient leaflet and implant card.

    Product
    Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2733-2024·2024-09-04

    GE Healthcare Proteus XR/a X-Ray System Missing De-Installation Manual

    GE Healthcare's Proteus XR/a stationary X-ray system lacks a required de-installation manual, creating risk of personnel injury during device removal.

    Product
    GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2130-2024·2024-06-26

    Ventilator Operator's Guide Recalled for Missing Critical MRI Safety Information

    ZOLL is recalling operator's guides for the ZOLL 731 Ventilator because they omit critical MRI safety information. Missing distance guidance could cause the ventilator to malfunction during MRI procedures.

    Product
    ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2024·2023-11-01

    PrestiBio Urinalysis Test Strips Recalled for Unverified Manufacturing

    Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS due to missing manufacturing documentation and unverified device performance. The manufacturer is ceasing operations and cannot demonstrate the devices meet quality standards.

    Product
    PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0058-2024·2023-11-01

    FDA Recalls Ovulation Test Strips for Unverified Manufacturing and Documentation

    FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.

    Product
    DiagnosUS One Step LH Ovulation Test Strip REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0050-2024·2023-11-01

    Pregnancy test strips recalled due to manufacturing documentation gaps

    Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.

    Product
    To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0717-2020·2019-12-25

    Boston Scientific Recalls AngioJet Ultra Consoles Missing Operator's Manuals

    Boston Scientific is recalling 169 AngioJet Ultra Consoles because they were shipped without the required Operator's Manual.

    Product
    AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0510-2019·2018-12-05

    Numed Multi-Track Angiographic Catheter Recall for Missing Instructions

    Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because the Instructions for Use booklets were not included on the outer pouch.

    Product
    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1166-2018·2018-03-28

    Arrow International Recalls Central Venous Catheter Kits Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits because they lack required safety checklists and procedure notes.

    Product
    ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1161-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Guides

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical procedure notes and checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1164-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Documentation

    Arrow International is recalling 18,124 central venous catheter kits because they lack required clinical guidance documents. The recall is nationwide.

    Product
    Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2018·2018-03-28

    Arrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists

    Arrow International is recalling 18,124 percutaneous sheath introducer kits because they lack required central line insertion checklists and procedure notes.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1159-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Guidance Documents

    Arrow International is recalling 18,124 central venous catheterization kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required procedural notes and insertion checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1160-2018·2018-03-28

    Arrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists

    Arrow International is recalling 18,124 percutaneous sheath introducer kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.

    Product
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1162-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical safety checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3209-2017·2017-10-04

    Zimmer Dental Waxing Coping Recall Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling dental waxing copings because they were shipped with only standard instructions, missing required supplemental IFUs.

    Product
    WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3204-2017·2017-10-04

    Zimmer Dental Guide Sleeves Recalled for Missing Supplemental Instructions

    Zimmer Biomet is recalling specific dental guide sleeves because they were shipped with only standard instructions, missing required supplemental instructions.

    Product
    Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3210-2017·2017-10-04

    Zimmer Dental Recalls Implants Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling 169 dental implants because they were shipped without supplemental instructions for use.

    Product
    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1411-2017·2017-03-15

    Mako Surgical Recalls MAKO RIO THA Application User Guides

    Mako Surgical Corporation is recalling 777 MAKO RIO THA Application User Guides because five AFMEA Risk Control Measures are missing from the documents.

    Product
    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1424-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling nine Biograph Mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population of devices.

    Product
    Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2017·2017-03-15

    Siemens Biograph 6 TruePoint PET/CT Recall for Missing Instructions

    Siemens is recalling 18 Biograph 6 TruePoint mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population.

    Product
    Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2013·2013-06-05

    Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions

    Spinal Solutions is recalling loaner bins and sterilization trays for spinal implants because directions for use and surgical techniques were not provided to every physician.

    Product
    Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide