Hazard

Documentation Error recalls

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

What the numbers show

Total: 426
Critical: 0
Severe: 0
Most recent: 2026-09-02

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

About this hazard tag

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.

401–425 of 426

ModerateFDA (Devices)·Z-1385-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 50 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.
Product
Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standa
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1378-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.
Product
Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral compone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1417-2013·2013-06-05
Spinal Solutions Recalls Copperhead IBFD Loaner Bins Due to Missing Instructions
Spinal Solutions is recalling Copperhead IBFD loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a va
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1384-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.
Product
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1379-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants and instruments because directions for use and surgical techniques were not provided to every physician for every surgery.
Product
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1380-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays
Orthopedic Alliance LLC is recalling 57 units of loaner bins and sterilization trays because surgical instructions were not provided to every physician.
Product
UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1381-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues
Orthopedic Alliance LLC is recalling 30 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads po
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1217-2013·2013-05-29
Cefla Dental X-Ray Units Recalled for Missing Safety Labels
Cefla Dental Group is recalling 173 MyRay RXDC dental x-ray units because they lack required certification and identification labels.
Product
MyRay RXDC dental unit x-ray unit
Category
Medical Device
Distribution
22 states
ModerateNHTSA·13V216000·2013-05-21
Lotus Recalls 2013 Evora Vehicles for Incorrect Federal Certification Labels
Lotus is recalling 28 model year 2013 Evora vehicles because they lack required temporary exemption labels and have incorrect dates on federal certification labels.
Product
LOTUS — LOTUS EVORA
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1216-2013·2013-05-15
Karl Storz Recalls Photodynamic Diagnosis Instruction Manuals for Safety Updates
Karl Storz is recalling 15 units of PDD D-Light C System instruction manuals because they contain important safety-related changes.
Product
KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1110-2013·2013-04-24
Intuitive Surgical da Vinci System User Manual Recall for Sterile Adapter Instructions
Intuitive Surgical is recalling IS3000 user manuals for da Vinci Si and Si-e systems to provide revised instructions for sterile adapter engagement and instrument installation.
Product
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1109-2013·2013-04-24
Intuitive Surgical Recalls da Vinci S User Manual for Sterile Adapter Instructions
Intuitive Surgical is recalling IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.
Product
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1125-2013·2013-04-24
Instrumentation Industries Recalls Manual Jet Ventilators for Updated Directions
Instrumentation Industries is recalling specific manual jet ventilators and accessories to replace previously distributed Directions for Use with updated versions.
Product
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet
Category
Medical Device
Distribution
44 states
ModerateFDA (Devices)·Z-1024-2013·2013-04-10
Zyno Medical Recalls Z-800 Volumetric Infusion Systems for Software Update
Zyno Medical LLC is recalling 2,589 Z-800 Volumetric Infusion Systems to update the Preventative Maintenance schedule and add software to monitor fluid volume.
Product
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0565-2013·2012-12-26
Del Mar Reynolds Medical Recalls BleaseFocus Anesthesia Workstations Due to Manual Error
Del Mar Reynolds Medical is recalling BleaseFocus Anesthesia Workstations and 700/900 Series Ventilators because the user manuals describe a secondary oxygen supply failure alarm that is not actually installed in the devices.
Product
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would co
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0342-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0332-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0156-2013·2012-10-31
Baxa Repeater Pump Recall Issued for Contradictory Operator Manual Instructions
Baxa Corporation is recalling Repeater Pump models 095, 099, and 099R because the included Technical Manual contradicts the Operator Manual regarding multiple source container use.
Product
Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2444-2012·2012-10-03
RaySearch SharePlan Software Recalled for Unexpected Import Behavior
RaySearch Laboratories is recalling SharePlan 1.1 software due to unexpected behavior when importing specific files. The issue has not caused patient mistreatment.
Product
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2368-2012·2012-09-19
Lucero Medical Recalls Enduramesh Spacers Due to Sterilization Validation Failure
Lucero Medical LLC is voluntarily recalling 169 Enduramesh Corpectomy Spacer Systems because the sterilization recommendations on the product insert did not pass sterilization validation.
Product
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2340-2012·2012-09-19
Elekta Agility Multileaf Collimator Recall for Missing Compatibility Information
Elekta is recalling two Agility Multileaf Collimators because the original product information did not specify compatibility with the Dynamic Multileaf Collimator Apex add-on.
Product
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2248-2012·2012-08-29
Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues
Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues in product documentation and classification identified during a merger review.
Product
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal pr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2013-2012·2012-07-25
Abbott Molecular Bar Code Scanner User's Guide Recalled for Incorrect Bar Codes
Abbott Molecular is recalling the Bar Code Scanner User's Guide because incorrect bar codes may prevent proper language configuration of the scanner.
Product
Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended U
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1824-2012·2012-06-27
App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues
App Pharmaceuticals is recalling Heparin Lock Flush Solution vials due to incomplete documentation of test results. The recall covers 133,150 vials distributed nationwide and in Puerto Rico.
Product
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood s
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1825-2012·2012-06-27
App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues
App Pharmaceuticals is recalling specific lots of Heparin Lock Flush Solution because of incomplete documentation associated with test results.
Product
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, ND
Category
Medical Device
Distribution
Distributed nationwide