The Recall Desk

Hazard

Documentation recalls

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

What the numbers show

Total
38
Critical
0
Severe
1
Most recent
2026-05-13

Of the 38 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 (3%) 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 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 38

  • ModerateFDA (Devices)·Z-2079-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps recalled for instructions update

    Katalyst Surgical is issuing a Field Safety Corrective Action for DEX Ophthalmic Tissue Forceps (Model DVF4034-25-S) due to instructions-for-use (IFU) corrections needed.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1358-2026·2026-02-18

    Newborn monitor caps recalled over an incorrect sizing guide on labeling

    SurePulse Medical is recalling the Surepulse VS Cap Medium because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1359-2026·2026-02-18

    Large newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Large because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1357-2026·2026-02-18

    Small newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Small because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1356-2026·2026-02-18

    Extra small newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Extra Small because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1360-2026·2026-02-18

    Extra large newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Extra Large because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0297-2026·2026-02-04

    Mouthwash recalled over missing or illegible lot and expiry coding

    Haleon is recalling 84,764 bottles of parodontax Active Gum Health Mouthwash, Mint, over the potential for missing or illegible lot and expiration date coding on the bottles.

    Product
    PARODONTAX — PARODONTAX (CETYLPYRIDINIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1130-2026·2026-01-28

    Surgical laser consoles recalled over a label missing the DANGER symbol

    Leaseir Technologies is recalling two MHR Xcell surgical laser systems because the console label on the affected devices is missing the "DANGER" symbol.

    Product
    Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1048-2026·2026-01-21

    Infusion system software recalled to emphasize instructions in the manual

    Fresenius Kabi is recalling 30 units of Ivenix Infusion System LVP software to emphasize the instructions for LVP duration programming set out in the IFU.

    Product
    Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0998-2026·2026-01-14

    Laser tracking system recalled over laser information omitted from instructions

    Vision RT is recalling 56 AlignRT InBore systems because information identifying the lasers and their characteristics was omitted from the Instructions for Use.

    Product
    The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0937-2026·2025-12-24

    Spinal navigation guide recalled for naming an incompatible toolcard system

    SeaSpine Orthopedics is recalling 310 NorthStar OCT Navigation items because the surgical technique guide incorrectly identified Medtronic Infinity toolcards as compatible.

    Product
    Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-4001
    Category
    Medical Device
    Distribution
    24 states
  • LowFDA (Devices)·Z-0916-2026·2025-12-17

    Hybrid balloon pumps recalled with a revised preventative maintenance schedule

    Datascope is recalling 11,470 Cardiosave Hybrid Intra-Aortic Balloon Pump systems to issue an instructions for use addendum revising the preventative maintenance schedule.

    Product
    Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0917-2026·2025-12-17

    Balloon pump systems recalled with a revised preventative maintenance schedule

    Datascope is recalling 47 Cardiosave Rescue Intra-Aortic Balloon Pump systems to issue an instructions for use addendum revising the preventative maintenance schedule.

    Product
    Cardiosave Rescue. Intra-Aortic Balloon Pump system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0872-2026·2025-12-10

    Olympus OER-Elite devices recalled with a notice on warnings and maintenance

    Aizu Olympus is issuing a recall covering 6,578 OER-Elite units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.

    Product
    Olympus OER-Elite
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0874-2026·2025-12-10

    Olympus OER-Mini devices recalled with a notice on warnings and maintenance

    Aizu Olympus is issuing a recall covering 6,578 OER-Mini units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.

    Product
    Olympus OER-Mini
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0873-2026·2025-12-10

    Olympus OER-Pro devices recalled with a notice on warnings and maintenance

    Aizu Olympus is issuing a recall covering 6,578 OER-Pro units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.

    Product
    Olympus OER-Pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0666-2026·2025-12-03

    Liquid biopsy reports recalled for omitting the companion diagnostic claims page

    Foundation Medicine is recalling 18 FoundationOne Liquid CDx reports that were sent to customers without the companion diagnostic Claims Page.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0656-2026·2025-12-03

    Bronchoscopy robots recalled because the user manual was password protected

    Noah Medical is recalling 47 Galaxy Systems because users did not have access to the Instructions for Use and User Manual, which was password protected.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML
    Category
    Medical Device
    Distribution
    0 states
  • ModerateNHTSA·25V815000·2025-11-25

    2026 Chevrolet Silverado 1500, 2500, 3500 Missing Owner Manuals

    General Motors is recalling certain 2026 Chevrolet Silverado 1500, 2500, and 3500 vehicles because some may not have received an owner's manual during production. Without the manual, owners may not know how to safely use child restraint anchorages, increasing crash injury risk.

    Product
    CHEVROLET — CHEVROLET SILVERADO 1500, SILVERADO 2500, SILVERADO 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0582-2018·2018-03-14

    Kalchem Recalls Vardenafil HCl Due to Missing Stability Data

    Kalchem International is recalling Vardenafil HCl 500 GM jars due to a lack of stability data supporting the expiration date.

    Product
    Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2812-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/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, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2017·2017-08-16

    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 of insufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,400/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, mitigation
    Category
    Medical Device
    Distribution
    Distributed nationwide