Hazard
429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
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.
Which agencies issued them
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.
Cytocell Ltd. is recalling a diagnostic reagent due to an error in the chromomap on the package insert. The nucleotide locations in the text are correct, but the chromosome map was created using incorrect coordinates.
Smiths Medical's Medfusion 4000 infusion pump software may delay sending infusion start messages to Electronic Health Record systems, potentially affecting infusion programming and clinical documentation.
DePuy Spine's EIT CIF intervertebral fusion cage (46 units, Part No. CUI8070S) is recalled due to a labeling discrepancy where the outer carton label does not match the labels on the product packaging and patient materials.
The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.
Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.
Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.
Smith & Nephew is recalling 35 units of EVOS Condylar Medial Distal Femur Plate due to incorrect MRI scanning safety information in the product instructions. The instructions contained erroneous data that could affect patient safety during MRI procedures.
FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.
Yamaha is recalling 2021 Tracer 9 GT motorcycles because the VIN on the certification label may not match the vehicle's stamped VIN, potentially preventing owners from receiving safety recall remedies.
The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.
MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.
Mylan Institutional LLC is recalling Thiamine Hydrochloride Injection USP 200 mg/2 mL due to vials labeled with incorrect lot numbers. The cartons contain the correct lot number 200906 but vials inside are labeled with lot number 200901.
Heartware, Inc. is updating the Instructions for Use and Patient Manual for the HVAD System to clarify carrying case care, driveline cover orientation, and controller power-up sequences.
Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System to update guidance on intermittent alarm issues.
Daimler Vans USA is recalling one 2019 Mercedes-Benz Sprinter because its VIN numbers do not match, potentially preventing owners from receiving safety recall notices.
Merz North America is recalling 2,051 units of COAPTITE Injectable Implant because the Instructions for Use do not match post-approval study data.
Blue Ortho is recalling 3,471 GPS Tracker Instructions For Use documents because some low-temperature sterilization conditions were approved based on rational documents.
Cook Inc. is recalling 368 Percutaneous Neonatal Pigtail Nephrostomy Sets because the indwell time is decreasing from 4 months to 4 weeks.
LuMaZu, LLC dba Nettle Meadow is recalling two cases of Habanero Peach Fromage Frais because pasteurization temperatures were not recorded due to a recorder malfunction.
LuMaZu, LLC dba Nettle Meadow is recalling 16 units of Truffle Fromage Frais because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.
LuMaZu, LLC dba Nettle Meadow is recalling artisan cheese because pasteurization temperatures were not recorded for two lots due to a recorder malfunction.
Devicor Medical Products Inc is recalling 49 Neoprobe GDS Control Units distributed to China because the installed software version does not match the approved version.
Biogen MA Inc. is recalling 3,922 bottles of Tecfidera (dimethyl fumarate) 240 mg capsules because a rejected lot was distributed to US markets.
Volkswagen is recalling two 2018 Golf GTI vehicles because the VIN on the Federal Certification label may not match the actual vehicle VIN, potentially preventing owners from identifying safety recalls.
Jayco is recalling certain 2019–2021 Class C motorhomes because the Operator's Manual contains incorrect information about the automatic parking function, which could lead to unintended vehicle movement or rollaway.