The Recall Desk

Hazard

Documentation Error recalls

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

What the numbers show

Total
426
Critical
0
Severe
0
Most recent
2026-09-02

Of the 426 documentation error 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 error 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.

101–125 of 426

  • ModerateFDA (Devices)·Z-0176-2019·2018-10-24

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Recall

    Terumo is recalling 152 Advanced Perfusion System 1 Electronic Patient Gas Systems because the service manual was not updated for software version 1.30.

    Product
    Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0062-2019·2018-10-10

    Dannoritzer Laparoscopy Instruments IFU Recalled for Unvalidated Cleaning Instructions

    Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for certain laparoscopy instruments because the manual cleaning process was not validated.

    Product
    Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1220-2018·2018-09-12

    AutoDELFIA Neonatal IRT Kit Recalled for Missing Quality Control Certificate Information

    PerkinElmer is recalling AutoDELFIA Neonatal IRT kits because missing quality control certificate information may delay reporting of IRT results.

    Product
    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2142-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recalled for Missing Warning Statements

    Philips is recalling 7,178 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2141-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2107-2018·2018-06-13

    MicroAire SmartRelease Endoscopic System Recalled for Incorrect Sterilization Instructions

    MicroAire is recalling SmartRelease Endoscopic Systems because the Instructions for Use contain incorrect sterilization parameters.

    Product
    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1695-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Change

    Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf life change was made without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1630-2018·2018-05-16

    Integra Manuka Honey Wound Gel Recalled for Incorrect Manufacturing Record

    Integra LifeSciences Corp. is recalling Manuka Honey Wound Gel due to an incorrect part number listed in a master manufacturing record.

    Product
    Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1598-2018·2018-05-09

    Stryker 6376 M-1 Cot Fastener Recalled for Missing Manual Warnings

    Stryker is recalling 59 M-1 Cot Fasteners distributed to the Netherlands because their operation and maintenance manuals are missing warnings and contain incorrect information.

    Product
    6376 M-1 Cot Fastener, catalog no. 6376000000
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1599-2018·2018-05-09

    Stryker 6381 M-1 Cot Fastener Recalled for Missing Manual Warnings

    Stryker is recalling three 6381 M-1 Cot Fasteners because their manuals contain incorrect information and missing warnings.

    Product
    6381 M-1 Cot Fastener, catalog no. 6381000000
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1544-2018·2018-05-09

    BD MAX DNA MMK Recalled for Incorrect Package Insert Volume Instructions

    Becton Dickinson is recalling BD MAX DNA MMK (SPC) because the package insert lists the wrong volume of diluent, which could affect assay results.

    Product
    BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1519-2018·2018-05-02

    Roche Acetaminophen Assay Method Sheets Missing Interference Statement

    Roche Diagnostics is recalling Acetaminophen assay method sheets for COBAS INTEGRA and MODULAR ANALYTICS systems because they omit a statement regarding potential interference from gammopathy.

    Product
    Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1383-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 2,714 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use are missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the hear
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 655 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions For Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the hear
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1152-2018·2018-03-28

    Arrow International Recalls ARROWg+ard Blue PLUS Catheters Due to Missing Lid Information

    Arrow International Inc is recalling 420 ARROWg+ard Blue PLUS catheters because certain lots may be missing lot numbers, expiration dates, and UDI information on the lid.

    Product
    ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against cat
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1000-2018·2018-03-21

    Arrow International Recalls Central Venous Access Kits Due to Missing Labels

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

    Product
    ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access 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 infus
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0516-2018·2018-02-28

    Phentolamine Mesylate Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Phentolamine Mesylate USP for prescription compounding due to missing stability data supporting expiration dates.

    Product
    Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2018·2018-02-28

    FDA Recalls Testosterone Enanthate USP Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Testosterone Enanthate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

    Product
    Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0509-2018·2018-02-28

    Liothyronine Sodium USP Recalled for Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Liothyronine Sodium USP for prescription compounding due to a lack of stability data supporting the expiration date.

    Product
    Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2018·2018-02-28

    FDA Recalls Estriol USP for Prescription Compounding Due to Stability Data Issues

    American Pharmaceutical Ingredients LLC is recalling Estriol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support expiration dates.

    Product
    Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2018·2018-02-28

    FDA Recalls Diphenhydramine HCl Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Diphenhydramine HCl USP f due to a lack of stability data supporting the assigned expiration date.

    Product
    Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0373-2018·2017-11-29

    Henning's Wisconsin Cheese Colby Jack Recalled Due to Pasteurization Record Failure

    Henning Cheese, Inc. is recalling 4,253 lbs of Colby Jack cheese because a temperature recorder failed to log pasteurization data for the first vat.

    Product
    Henning's Wisconsin Cheese Colby Jack, Colby & Monterey Jack Blended Together. Packaged in 1 lb., 2 lb, and mammoth wheels (A mammoth wheel can be classified as anything 75 lbs. and larger).
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-3206-2017·2017-10-04

    Zimmer Dental Recalls Abutment and Coping Products for Missing Instructions

    Zimmer Biomet is correcting dental abutments and copings because they were shipped with standard instructions but missing supplemental instructions.

    Product
    ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-3569-2017·2017-09-27

    Joy's Gourmet Olive Salad Recalled for Unrecorded Temperature Data

    Joy's International Foods is recalling 16 cases of Joy's Gourmet Olive Salad because temperature records were missing after thermal processing.

    Product
    Joy's Gourmet Olive Salad, All Natural, Net Wt. 10 OZ. (280g).
    Category
    Food
    Distribution
    0 states