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.

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 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.

26–50 of 135

ModerateFDA (Drugs)·D-1390-2020·2020-07-22
Preferred Pharmaceuticals Recalls Lidothol Patches Due to Missing Batch Records
Preferred Pharmaceuticals is recalling Lidothol Patches because the contract manufacturer misplaced or lost batch records and test results.
Product
Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals,
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1907-2020·2020-05-13
Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure
Gentell, Inc. is recalling 85,586 units of Gentell Honey Hydrogel 2"x2" Saturated Gauze because the product was not properly registered with the FDA.
Product
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, f
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1909-2020·2020-05-13
Gentell Honey Hydrogel Saturated Gauze Recalled for FDA Registration Failure
Gentell, Inc. is recalling 4,348 units of Gentell Honey Hydrogel Saturated Gauze because the product was not properly registered with the FDA.
Product
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers,
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1908-2020·2020-05-13
Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure
Gentell, Inc. is recalling 22,439 units of Gentell Honey Hydrogel 4"x4" Saturated Gauze because the product was not properly registered with the FDA.
Product
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1624-2020·2020-04-08
Gentell Hydrogel Ag Gauze Recalled for FDA Registration Deficiency
Gentell, Inc. is recalling 20,025 units of Gentell Hydrogel Ag 4x4 gauze because the product was not properly registered with the FDA.
Product
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1625-2020·2020-04-08
Gentell Hydrogel Ag Saturated Gauze Recalled for FDA Registration Deficiency
Gentell, Inc. is recalling 6,433 units of Gentell Hydrogel Ag Saturated Gauze because the product was not properly registered with the FDA.
Product
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0849-2020·2020-04-01
Proxy Foods Recalls Green Pozole Soup Starter Due to Missing Records
Proxy Foods LLC is recalling Green Pozole Soup Starter because the company is missing processing records and production logs for the product.
Product
Green Pozole Soup Starter, Pozole To The People, packaged in glass jars. Net Wt. 16 fl. oz., (473.2 mL). or 24 fl. oz. 16 fl oz UPC 738283379116 24 fl oz UPC 860322002218 The label is read in parts: "***GREEN POZOLE SOUP STARTER ***INGREDIENTS: Water, Hominy, Tomatillo, Po
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-0850-2020·2020-04-01
Proxy Foods Recalls White Corn Hominy Due to Missing Production Records
Proxy Foods LLC is recalling 96 jars of White Corn Hominy in Oregon and Washington because production logs are missing.
Product
White Corn Hominy, Pozole To The People, packaged in glass jars. Net Wt. 16 fl. oz., (473.2 mL). UPC 738283379147. The label is read in parts: "***WHITE CORN HOMINY ***INGREDIENTS: Water, White Corn Hominy, Sea Salt, Lime Juice ***Made by Proxy Foods, LLC 7328 SE Foster Road,
Category
Food
Distribution
2 states
LowFDA (Devices)·Z-0820-2020·2020-01-29
Koios DS Breast Software Recalled for Missing Quality Documentation
Koios Medical is recalling 10 units of Koios DS Breast software due to insufficient documentation of required quality procedures.
Product
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-0700-2020·2019-12-25
Allergan Recalls Natrelle Breast Implants Due to Unreadable 2D Barcodes
Allergan is recalling Natrelle silicone breast implants because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.
Product
Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel Roun
Category
Medical Device
Distribution
47 states
LowFDA (Devices)·Z-0607-2020·2019-12-11
Theralase Laser Power Pack Recalled for Missing UDI and False CE Mark
Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.
Product
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0562-2020·2019-12-04
Wright Medical Recalls Swanson Great Toe Implants Due to Sterility Documentation
Wright Medical Technology is recalling 30 Swanson Great Toe implants because the firm discovered a lack of adequate documentation confirming sterility.
Product
SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-1561-2019·2019-08-07
NingBo Huize Recalls Dippin' Dots Hand Gel for Missing Stability Testing
NingBo Huize is recalling Dippin' Dots Scented Birthday Cake Antibacterial Hand Gel because stability testing was not conducted on the product.
Product
DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1539-2019·2019-08-07
DOTS Scented Antibacterial Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling DOTS Scented Antibacterial Hand Gel Lime because stability testing was not conducted on the product.
Product
DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1544-2019·2019-08-07
NingBo Huize Recalls CHARMS Antibacterial Hand Gel for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Blue Razz Berry Scented Antibacterial Hand Gel because stability testing was not conducted.
Product
CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1560-2019·2019-08-07
Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling DIPPIN' DOTS Scented Banana Split Antibacterial Hand Gel because stability testing was not conducted.
Product
DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1554-2019·2019-08-07
NingBo Huize Recalls Air Heads Hand Gel for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Air Heads Pink Lemonade Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
Product
AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-1963-2019·2019-07-24
Zimmer Biomet Recalls Ultra-Drive Irrigation Tubing Assembly Due to Shelf Life Data
Zimmer Biomet is recalling 8,478 Ultra-Drive Irrigation Tubing Assemblies because the company lacks sufficient data to support the labeled 10-year shelf life.
Product
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1021-2019·2019-03-27
Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates
Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use.
Product
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1026-2019·2019-03-27
Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.
Product
Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cav
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1024-2019·2019-03-27
Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.
Product
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the foll
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0380-2019·2019-01-23
Lupin Recalls Cephalexin Oral Suspension Due to Missing Manufacturing Records
Lupin Pharmaceuticals is recalling 7,215 bottles of Cephalexin for Oral Suspension because the manufacturing batch record could not be located.
Product
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
Category
Drug
Distribution
0 states
LowFDA (Devices)·Z-0511-2019·2018-12-05
Numed Multi-Track Angiographic Catheter Recall for Missing Instructions
Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because Instructions for Use booklets were not included on the outer pouch.
Product
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0410-2019·2018-11-14
R&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error
R&D Systems is recalling eight Human Total 25-OH Vitamin D IVD ELISA Kits because they were shipped without lot-specific booklets and contained a calibrator vial with an incorrect reconstitution volume label.
Product
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1416-2018·2018-04-25
Terumo HX2 Temperature Management System Recall for Updated Cleaning Instructions
Terumo is recalling HX2 Temperature Management Systems to update cooler-heater cleaning instructions. The recall affects 2,393 units distributed worldwide.
Product
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Category
Medical Device
Distribution
Distributed nationwide