The Recall Desk

Hazard

Documentation Error recalls

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

What the numbers show

Total
429
Critical
0
Severe
1
Most recent
2026-10-14

Of the 429 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 1 (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.

1–25 of 429

  • ModerateFDA (Devices)·Z-0118-2027·2026-10-14

    Steris HexaVue Focus Integration System Recalled for Patient Data Mismatch

    Steris is recalling 58 HexaVue Focus Integration Systems because a software issue may cause incorrect patient information to appear on printed images.

    Product
    HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0115-2027·2026-10-14

    Mindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification

    Mindray DS USA, Inc. is recalling cPM Series Patient Monitor operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.

    Product
    cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0114-2027·2026-10-14

    Mindray Recalls Passport Series Patient Monitor Operator's Manuals

    Mindray DS USA, Inc. is recalling Passport Series Patient Monitor operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.

    Product
    Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3018-2026·2026-09-02

    ConMed Suture Anchor Recalled for Incorrect Patient Implant Card

    ConMed is recalling specific suture anchors because they may contain incorrect patient implant cards, which could lead to incorrect device identification and traceability.

    Product
    CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3015-2026·2026-09-02

    Henry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging

    Henry Schein Inc. is recalling specific lots of Structur 2 SC Temporary Resin Cartridge Refills because they were distributed with incorrect packaging and Instructions for Use.

    Product
    Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Product Code 1481; Lot 2533123 4) 114-3937, Mfr Product Code 1482; Lots 2533203…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1652-2026·2026-04-01

    Embrace standard drill tower surgical technique lists mixed-up article numbers

    Waldemar Link is recalling the Embrace Drill Tower, Standard/Lateral, because the surgical technique document has mixed-up article numbers in the instrument overview, although the surgical steps are correct.

    Product
    Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1651-2026·2026-04-01

    Embrace shoulder drill tower surgical technique lists mixed-up article numbers

    Waldemar Link is recalling the Embrace Drill Tower because the surgical technique document has mixed-up article numbers in the instrument overview, although the individual surgical steps are correct.

    Product
    Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2453-2025·2025-09-03

    Drug transfer devices recalled for shipping without US instructions for use

    BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.

    Product
    BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2463-2025·2025-09-03

    Leg massagers recalled over documentation error and misleading color packaging claim

    HoMedics Air Compression Leg Massagers, model SR-160HJ, are recalled for a regulatory documentation error and a misleading color packaging claim. The record states the affected lots do not present a risk of harm.

    Product
    Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2025·2025-07-02

    Jewel Precision Reusable Rigid Sterilization Container System Instructions Mismatch

    Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-6) is being recalled because the Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·25V417000·2025-06-27

    Bowlus trailer manual omits hitch bolt retightening from maintenance schedule

    Bowlus is recalling certain trailers with an elongated hitch because the owner's manual does not include instructions to retighten the two hitch bolts in the maintenance schedule.

    Product
    BOWLUS — BOWLUS ENDLESS HIGHWAYS, TERRA FIRMA, VOLTERRA, RIVET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2536-2024·2024-08-14

    Steris Hookup Model 2-8-540 Documentation Error Risks Improper Endoscope Disinfection

    Steris Hookup Model 2-8-540 instructions were incorrectly documented, potentially preventing proper endoscope disinfection and risking patient infection.

    Product
    Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·24V575000·2024-08-01

    2024 Chevrolet Malibu Vehicles Recalled for Wrong Owner Manual

    General Motors is recalling 2024 Chevrolet Malibu vehicles that may have an incorrect owner's manual. The wrong manual could contain inaccurate vehicle safety information.

    Product
    CHEVROLET — CHEVROLET, CADILLAC MALIBU, XT4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2024·2024-04-24

    Surgical and Cardiovascular Device Marketing Brochures Recalled for Documentation Errors

    Baxter Healthcare is recalling surgical and cardiovascular device marketing brochures that contain information conflicting with the official Instructions for Use. The inaccurate content could lead to incorrect device use.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2024·2024-04-24

    Baxter surgical tool marketing brochures contain inaccurate Instructions for Use

    Baxter Healthcare Corporation recalled marketing brochures for surgical tools that contain inaccurate information conflicting with the product Instructions for Use. Over 82,000 units were distributed worldwide.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1258-2024·2024-03-13

    Embrace Drill Tower Surgical Instruments Recalled Due to Mixed-Up Type Descriptions

    Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.

    Product
    Embrace Drill Tower, Standard/Lateral (25mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2024·2024-01-17

    Baxter Flo-Rester Vessel Occluder Recall Due to Inaccurate Marketing Brochure

    Baxter Healthcare is recalling Flo-Rester internal vessel occluders because marketing materials contain inaccurate information that doesn't match the product's Instructions for Use and Prescribing Information.

    Product
    Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0658-2024·2024-01-17

    Medical Device Recall: Baxter Ostene Hemostasis Material Marketing Brochure Inaccuracy

    Baxter Healthcare is recalling marketing materials for the Ostene Hemostasis Material due to inaccuracies that do not align with the product's official Instructions for Use and Prescribing Information.

    Product
    Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0657-2024·2024-01-17

    Baxter Coseal Premix Surgical Sealant: Marketing Brochure Information Inaccuracy

    Baxter Healthcare Corporation is recalling Coseal Premix Surgical Sealant due to inaccurate information in a marketing brochure that conflicts with the product's Instructions for Use and Prescribing Information.

    Product
    Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2024·2023-12-20

    CARDIOHELP-i Heart-Lung Support System: Incorrectly Documented Factory Settings

    The CARDIOHELP-i Heart-Lung Support System is recalled because factory settings were incorrectly described in the manual. Healthcare providers should verify device settings with the manufacturer.

    Product
    CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1019-2023·2023-02-01

    Air-Q3 intubating laryngeal airway size labeling discrepancy between IFU and device

    SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.

    Product
    Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0353-2023·2022-12-07

    Laboratory Diagnostic Probe Recalled for Incorrect Chromosome Map Labeling

    Cytocell Ltd. recalls CytoCell BCL11B Proximal probe used in T-cell malignancy testing (lot RD22/230/10). The package insert contains an incorrect chromosome map that doesn't match the probe design.

    Product
    CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781
    Category
    Medical Device
    Distribution
    1 state