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.

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 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.

51–75 of 135

  • LowFDA (Devices)·Z-1352-2018·2018-04-18

    Magstim Rapid Therapy System Recalled for Missing User Manuals

    The Magstim Company Limited is recalling 43 Magstim Rapid Therapy Systems because user manuals were not supplied with the devices.

    Product
    Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvemen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1005-2018·2018-03-21

    Arrow CVC Kit Recall for Missing Lot and UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0994-2018·2018-03-21

    Arrow Central Venous Catheter Kits Recalled for Missing Identification Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access i
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1003-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of flui
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1001-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 Arrowg+ard Blue Large-Bore Multi-Lumen CVC Kits because some units may be missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fl
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1004-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Stickers

    Arrow International Inc. is recalling 23,904 Arrowg+ard BLUE PLUS CVC Kits because some units are missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0512-2018·2018-02-28

    Nandrolone Decanoate USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Nandrolone Decanoate USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0534-2018·2018-02-28

    Verapamil HCl USP Recalled for Missing Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Verapamil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.

    Product
    Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0535-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Ascorbic Acid Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Ascorbic Acid USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland R
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3207-2017·2017-10-04

    Zimmer Dental Recalls Try-In Abutments Due to Missing Supplemental Instructions

    Zimmer Biomet is recalling specific dental try-in abutments because they were shipped with standard instructions but lacked required supplemental instructions.

    Product
    TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3208-2017·2017-10-04

    Zimmer Dental Recalls Impression Caps Due to Missing Supplemental Instructions

    Zimmer Biomet is conducting a field correction for dental impression caps because they were shipped without supplemental instructions for use.

    Product
    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESS
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-3132-2017·2017-09-20

    Boston Scientific Recalls FFR Link Signal Processing Modules for Missing Test Records

    Boston Scientific is recalling three FFR Link Signal Processing Modules because the device history record was missing documentation for final electrical testing.

    Product
    FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they c
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2848-2017·2017-08-16

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

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

    Product
    Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case, 1,000/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, mitigatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2668-2017·2017-07-12

    Exactech Equinoxe Reamer Recall Due to Updated Instructions for Use

    Exactech is recalling Equinoxe Narrow Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2540-2017·2017-06-21

    Cook Inc. Recalls Vue Optic Endoscopes Due to Insufficient Reprocessing Instructions

    Cook Inc. is voluntarily recalling Vue Optic Visualization Sources and Flexor Vue Deflecting Endoscopic Systems because current reprocessing instructions lack sufficient detail for cleaning and sterilization.

    Product
    Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-2539-2017·2017-06-21

    Cook Multi-Use Holmium Laser Fibers Recalled for Reprocessing Instruction Deficiencies

    Cook Inc. is recalling 4,369 multi-use holmium laser fibers because the current instructions for use do not provide sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-2312-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Plates Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1944-2017·2017-05-10

    Anspach Effort Recalls XMAX Pneumatic Drill System for Missing Service Interval

    The Anspach Effort, Inc. is recalling 554 XMAX Pneumatic Drill Systems because the supplied directions for use did not include a recommended service interval.

    Product
    XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1941-2017·2017-05-10

    Anspach Effort Recalls BLACKMAX-NEURO Pneumatic System for Missing Service Interval

    The Anspach Effort, Inc. is recalling 25 BLACKMAX-NEURO LOW PRESSURE pneumatic systems because the supplied directions for use did not include a recommended service interval.

    Product
    BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide