The Recall Desk

Hazard

Documentation Deficiency recalls

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

What the numbers show

Total
66
Critical
0
Severe
0
Most recent
2024-11-13

Of the 66 documentation deficiency 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 deficiency 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 66

  • LowFDA (Food)·F-0108-2025·2024-11-13

    MyChai Chai Tea Concentrate Recalled for Missing Production Records

    My Chai Inc is recalling 11,202 jugs of MyChai Chai Tea Concentrate nationwide due to missing production records.

    Product
    MyChai Chai Tea Concentrate Double. Product is packaged in the same square 0.5 gallon HDPE plastic bottles and have volumes of 68 fl oz. Ingredients: Water, Sugar, Organic Black Tea, Organic Spices, Molasses, Vanilla Extract, Citric Acid, Natural Flavors. Made by: MyChai, Inc.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2024·2023-11-01

    Unauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech

    Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.

    Product
    Lem Fertility hCG Pregnancy Urine Test REF 100-12
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1078-2022·2022-05-25

    Getinge Washer Disinfector models recalled for inadequate installation documentation

    Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.

    Product
    Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2304-2020·2020-06-17

    Biomet 8.0 Cannulated Screw Tap Recalled for Incomplete Design History Files

    Biomet is recalling 8.0 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.

    Product
    Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History

    Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2020·2020-06-17

    Biomet Recalls A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2310-2020·2020-06-17

    Biomet A.L.P.S. T15 Multi-Directional Locking Screw Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. T15 Multi-Directional Locking Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2312-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History

    Biomet is recalling 78 units of A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2322-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History

    Biomet is recalling specific lots of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2020·2020-06-17

    Biomet Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2324-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Design History Deficiencies

    Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because it was distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2306-2020·2020-06-17

    Biomet A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeve Recalled

    Biomet is recalling A.L.P.S Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2318-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design Documentation Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2020·2020-06-17

    Biomet Recalls A.L.P.S. Proximal Humerus Plating System for Design Documentation Issues

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System plates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Drill Bit Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Calibrated Drill Bits because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Locking Pegs Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Locking Pegs 60mm because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2308-2020·2020-06-17

    Biomet A.L.P.S. Cortical Screw Recalled for Incomplete Design History

    Biomet is recalling A.L.P.S. T15 Low Profile Cortical Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files

    Biomet is recalling 16 units of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files

    Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because units were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2303-2020·2020-06-17

    Biomet 6.5 Cannulated Screw Tap Recalled for Incomplete Design History

    Biomet is recalling 6.5 Cannulated Screw Taps because they were distributed without completed design history files or design transfer activities.

    Product
    Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2019·2019-05-15

    Elekta Unity Systems Recalled for Missing Contrast Agent Warnings

    Elekta Limited is recalling nine Elekta Unity systems because the user manual lacks a warning regarding the administration of unvalidated contrast agents.

    Product
    Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in acco
    Category
    Medical Device
    Distribution
    Distributed nationwide