Hazard
426 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 426 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 0 (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.
The Anspach Effort, Inc. is recalling 462 System Console units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 5,757 units of the 5.0cm Short Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling three IMRI Motor pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 375 units of 7.5cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 10 units of the 90 Degree Right Angle Attach, Black Max, because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 Small Attachment, J-Latch units because the supplied directions for use did not contain a recommended service interval.
Zimmer Trabecular Metal Technology, Inc. is recalling the TM Ardis Interbody System due to a procedural error in the approval of literature, resulting in the unauthorized release of certain content.
The Anspach Effort, Inc. is recalling five AL-III-DISS Adapters because the supplied directions for use did not contain a recommended service interval.
ReVision Optics is recalling 1,279 Raindrop Near Vision Inlays to update instructions for use regarding irrigation and medication timing.
Merge Healthcare is recalling Unity PACS software version 11.0 because reports faxed to referring physicians were missing demographic header information.
Philips Medical Systems is recalling 425 BrightView XCT systems because the intended use listed in the instructions for use did not match the 510K submission.
Endologix is correcting cumulative clinical data reports for the AFX Endovascular AAA System and Powerlink System. This action applies to procedures conducted after June 2013.
Acumed LLC is recalling 83 units of OPT Croutons synthetic bone substitute because documentation for the sterilization dose was inadequate. The product was distributed in ten US states and Puerto Rico.
Bausch & Lomb is recalling Algerbrush-II surgical instruments because some units shipped with outdated operating instructions.
Philips Medical Systems is recalling one Brilliance iCT system because the installation of four M12 bolts was not correctly documented.
Pentax of America is recalling video colonoscopes shipped between April 2014 and September 2015 because they included outdated instruction manuals and lacked required reprocessing adaptors.
New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
The Anspach Effort, Inc. is recalling 88 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.
Alcon Research is recalling 8,646 units of the LAUREATE World Phaco System because steps 16-25 are missing from the Directions for Use.
Ellipse A/S is recalling 25 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.
Ellipse A/S is recalling 14 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.
Fujifilm Medical Systems is correcting the ED-250XL5 endoscope operations manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Fujifilm Medical Systems is recalling 882 ED-250XT5 endoscope operations manuals following reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Siemens Healthcare Diagnostics is recalling the ADVIA Centaur CP Immunoassay System because inaccuracies in the Operator's Guide may cause sample processing issues when using EZee-Nest Insert Cups.
Baxter Healthcare is recalling 10 automated peritoneal dialysis cyclers because the clinician guide lacks instructions for priming the patient line.