Dannoritzer Laparoscopy Instruments IFU Recalled for Unvalidated Cleaning Instructions
Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for certain laparoscopy instruments because the manual cleaning process was not validated.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and validation error regarding cleaning instructions, not a direct product defect causing injury.
Plain-English summary
Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for specific laparoscopy instruments, including monopolar electrodes, modular forceps or scissors components, and one-piece forceps or scissors for electrosurgical coagulation. The recall is due to the fact that the manual cleaning process and the usability of the reprocessing instructions had not been validated.
The affected products were distributed in the United States in the states of Ohio, Michigan, Massachusetts, California, Oklahoma, Tennessee, Georgia, Florida, Illinois, North Carolina, Texas, and Missouri. The Instructions For Use have been modified to remove the manual cleaning method and to revise the instructions for clarity and readability.
Healthcare facilities and users should stop using the affected Instructions For Use and contact the recalling firm for revised documentation. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
- Manufacturer
- Dannoritzer Medizintechnik GmbH & Co. KG
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- none
Distribution
Related recalls
Same hazard · documentation error
See all →- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateInstrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
FDA (Devices) · 2014-10-08
- ModerateInstrumed Recalls Reusable Laparoscopic Instruments for Updated Safety Instructions
FDA (Devices) · 2014-10-08
- ModerateStryker Pennington Forceps Recalled Due to Sterilization Instructions Error
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
FDA (Devices) · 2014-12-24
- HighKarl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- ModerateStryker Johann Forceps Recalled for Sterilization Instructions Error
FDA (Devices) · 2014-12-24