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.

101–125 of 135

ModerateFDA (Devices)·Z-2184-2015·2015-07-29
FDA Recalls American Medical Systems Fiber Strippers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1005-2015·2015-01-28
Arrow International Recalls Multi-Lumen CVC Kits Due to Missing Instructions
Arrow International Inc is recalling 420 Multi-Lumen PI CVC Kits and PSI Kits because the Instructions for Use were inadvertently removed from the packaging.
Product
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is i
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0766-2015·2014-12-24
Stryker Laparoscopic Grasper Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 20CM, P/N 0250282008 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0653-2015·2014-12-24
Stryker Kelly Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Kelly Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports whic
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0609-2015·2014-12-24
Stryker Laparoscopic Hook Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, HOOK SCISSORS, P/N 0250080020. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0681-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0672-2015·2014-12-24
Stryker Endoscopy Recalls ATRAUMATIC FORCEPS Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of ATRAUMATIC FORCEPS because the provided instructions do not support specific sterilization methods.
Product
PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) port
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0689-2015·2014-12-24
Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.
Product
PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which al
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2729-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling 15 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2181-2014·2014-08-20
Beevers Recalls Luma Wrap Phototherapy Swaddlers for Regulatory Misclassification
Beevers Manufacturing is recalling Luma Wrap neonatal phototherapy swaddlers because they were marketed without a required FDA 510(k) clearance.
Product
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2189-2014·2014-08-20
Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use
Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management o
Category
Medical Device
Distribution
43 states
LowFDA (Devices)·Z-2127-2014·2014-08-06
Small Bone Innovations Recalls AutoFIX Cannulated Compression Screw Systems for IFU Update
Small Bone Innovations is recalling 506 units of 3.0/4.0mm AutoFIX Cannulated Compression Screw Systems to update the Instructions for Use (IFU).
Product
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corre
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1663-2014·2014-06-04
Siemens Recalls MAGNETOM Aera Systems Due to Missing Operator Manuals
Siemens is recalling five MAGNETOM Aera magnetic resonance systems because a processing error may have prevented some users from receiving their Operator Manuals.
Product
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or func
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1468-2014·2014-04-23
Codman Certas Programmable Valves Recalled for Missing Verification Tools
Codman & Shurtleff is recalling 9,445 units of Certas Programmable Valves to ensure customers have tools to verify valve settings and location on x-ray images.
Product
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Cath
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1297-2014·2014-04-02
TriVascular Ovation Prime Abdominal Stent Graft System Instructions for Use Update
TriVascular, Inc. is notifying European physician users of the Ovation Prime Abdominal Stent Graft System about changes to the Instructions for Use.
Product
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurys
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1964-2013·2013-08-28
Philips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use
Philips Healthcare is recalling MobileDiagnost wDR systems because the Instructions for Use fail to comply with a Federal standard regarding generator value tolerance levels.
Product
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1653-2013·2013-07-10
Penlon Delta Anesthetic Vaporizer Recalled for Manual Clarity Improvements
Penlon Ltd is recalling Delta Vaporizers to update the User Manual with clearer installation and pre-use check instructions.
Product
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Category
Medical Device
Distribution
10 states
LowFDA (Devices)·Z-1447-2013·2013-06-26
Philips Radiographic Systems Recalled for Non-Compliant Installation Test Documents
Philips Healthcare is recalling 177 stationary radiographic systems because their Installation Acceptance Test Documents were non-compliant with regulations or could not be located.
Product
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1449-2013·2013-06-26
Philips BuckyDiagnost Radiographic X-ray System Recalled for Documentation Issues
Philips Healthcare Inc. is recalling 66 BuckyDiagnost Radiographic X-ray systems because installation acceptance test documentation was missing or inconsistent.
Product
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1382-2013·2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 21 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm Femora
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1412-2013·2013-06-05
Spinal Solutions Recalls 40 mm Rods Due to Missing Surgical Instructions
Spinal Solutions is recalling 63 units of 40 mm Rods because directions for use and surgical techniques were not provided to every physician.
Product
40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0643-2013·2013-01-16
Philips HeartStart HS1 Defibrillators Recalled for Manual Clarification
Philips is recalling HeartStart HS1 defibrillators to clarify maintenance information in the Owner's Manual.
Product
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0341-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit 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, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. 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 bleedin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0336-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit 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, 2x2 Pledget, 1.5%, Part# 9105-00. 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 capil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0331-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly sterility audits were performed.
Product
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. 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, eithe
Category
Medical Device
Distribution
Distributed nationwide