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.

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.

76–100 of 135

  • LowFDA (Devices)·Z-1951-2017·2017-05-10

    Anspach Effort Recalls eMax2 Hybrid Hand Control for Missing Service Interval

    The Anspach Effort, Inc. is recalling 293 eMax2 Hybrid Hand Controls because the supplied directions for use did not contain a recommended service interval.

    Product
    eMax2 Hybrid Hand Control Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1949-2017·2017-05-10

    Anspach Effort Recalls Electronic Foot Controls Due to Missing Service Interval

    The Anspach Effort, Inc. is recalling 821 Electronic Foot Controls because the supplied directions for use did not contain a recommended service interval.

    Product
    Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1698-2017·2017-04-05

    AGFA DX-D100 X-Ray System Recalled for Missing Allen Wrench Storage Instructions

    AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.

    Product
    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
    Category
    Medical Device
    Distribution
    35 states
  • LowFDA (Devices)·Z-1423-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens Medical Solutions is recalling six Biograph Mobile PET/CT units because mobile-specific instructions were not shipped to a limited population of systems.

    Product
    Biograph 6 TruePoint, Material Number 10097290 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 d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1238-2017·2017-03-01

    Hidrex Recalls Daavlin Aquex Devices Due to Documentation Requirements

    Hidrex GmbH is recalling 250 Daavlin Aquex (DAAV1000) devices nationwide because the device was reclassified from Class III to Class II, triggering new documentation requirements.

    Product
    Daavlin Aquex (DAAV1000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1075-2017·2017-02-01

    Pentax Rigid Laryngostroboscopes Field Correction for Instructions for Use

    Pentax of America is revising the Instructions for Use for Rigid Laryngostroboscopes Models 9106 and 9108.

    Product
    Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1059-2017·2017-02-01

    GE OEC 9800 Surgical Table Field Action for Documentation Updates

    GE Healthcare is updating user documentation for OEC 9800 surgical tables to clarify maintenance and component replacement schedules.

    Product
    OEC 9800. MDL Numbers: D222250, D141598
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1060-2017·2017-02-01

    GE OEC 9900 Elite Surgical Carts Recalled for Documentation Updates

    GE Healthcare is updating user documentation for OEC 9900 Elite surgical carts to clarify maintenance and component replacement frequencies.

    Product
    OEC 9900 Elite. MDL Numbers: D148942, D155043
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0982-2017·2017-01-18

    Bard Access Systems Recalls StatLock Catheter Stabilization Devices

    Bard Access Systems is voluntarily recalling StatLock CV Plus catheter stabilization devices because some pouches lack unique product identifiers.

    Product
    StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0937-2017·2017-01-04

    Sterling Diagnostics Recalls Enzymatic Uric Acid Diagnostic Kits

    Sterling Diagnostics is recalling 173 Enzymatic Uric Acid diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0683-2017·2016-12-21

    Galliker's Lemon Iced Tea Recalled for Missing Pasteurization Documentation

    Galliker Dairy Co. is recalling 2,851 gallon jugs of lemon iced tea because the products were labeled as pasteurized without legal documentation to support the claim.

    Product
    Galliker's Lemon Iced Tea Flavored, 1 GAL and Galliker's Lemon Flavored Iced Tea, 1/2 GAL
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0318-2017·2016-11-02

    Pentax Video Gastroscope Recall for Updated Operation and Reprocessing Instructions

    Pentax of America Inc is recalling video gastroscopes to provide customers with the most recent Operation and Reprocessing Instructions (IFUs).

    Product
    Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0040-2017·2016-10-19

    Schafer Fisheries Recalls Twin Fin Deli Salami Due to Recordkeeping Issues

    Schafer Fisheries is recalling Twin Fin Deli Salami because the company lacked adequate HACCP records. The product was distributed in Illinois, New York, and California.

    Product
    Label reads in part: TWIN FIN DELI; Salami; Net WT. 1lb (453g); P.O. Box 399 Thomson IL, FDA# 1481764 Thomason
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1186-2016·2016-03-23

    Sorin Recalls Stockert Heater-Cooler 3T Units for Instruction Manual Updates

    Sorin Group USA is recalling 1,125 Stockert Heater-Cooler 3T units to update instruction manuals with water quality enhancements.

    Product
    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1019-2016·2016-03-09

    Virage OCT Spinal Fixation System Recall for Updated Surgical Guidance

    Zimmer Spine is issuing a Class II correction for the Virage OCT Spinal Fixation System to provide additional guidance in the surgical technique manual.

    Product
    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0687-2016·2016-01-27

    Siemens e.cam Gamma Camera Recall for Missing Operator Manuals

    Siemens is recalling 10 refurbished e.cam Dual Signature Gamma Camera systems because complete operator instruction manuals were not sent to customers.

    Product
    The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-2348-2015·2015-08-12

    Zimmer Surgical Recalls Tourniquet Cuffs Due to Missing Instructions

    Zimmer Surgical Inc. is recalling 61 units of 18-inch disposable tourniquet cuffs because the folded instructions for use pamphlet was missing usage instructions and warnings.

    Product
    18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tournique
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2247-2015·2015-08-05

    EXP Recalls Unregistered Surgical Routers for Crani-A Procedures

    EXP Pharmaceutical Services Corp is recalling four surgical routers because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2277-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2276-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiological Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiological media products, including BEA Agar with Vancomycin, because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vanco
    Category
    Medical Device
    Distribution
    Distributed nationwide