WOM World of Medicine Recalls PNEUMOCLEAR Heated High-Flow Tube Sets
WOM World of Medicine AG is recalling PNEUMOCLEAR Heated High-Flow Tube Sets because packaging may be damaged by the tube set prongs.
What this means for you
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 II, but the specific hazard is limited to potential packaging damage without reported injuries or illnesses, aligning with the criteria for packaging-only problems.
Plain-English summary
WOM World of Medicine AG is recalling 124,180 units of the PNEUMOCLEAR Heated High-Flow Tube Set. The recall is due to a potential defect where the prongs on the tube set may damage the product packaging.
The affected product is a single-use sterile tube set used as an accessory with the PNEUMOCLEAR CO2 insufflator during diagnostic and therapeutic endoscopic procedures. The recall covers lots 4011926 through 4013513. The products were distributed worldwide, specifically in the state of California in the United States and in the Netherlands.
Consumers and healthcare providers should stop using the affected tube sets and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnost
- Manufacturer
- WOM World of Medicine AG
- Hazard
- Affected units
- 124,180
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)
- Lots from 4011926 to 4013513 (ALL)
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · WOM World of Medicine AG
See all →- ModerateWOM Tube Set for Irrigation Recalled Due to RFID Tag Data Error
FDA (Devices) · 2024-07-10
- HighAquilex Fluid Control System May Cause Fluid Overload During Hysteroscopy
FDA (Devices) · 2023-10-04
- HighFluid management system control unit display freeze during hysteroscopic procedures
FDA (Devices) · 2021-10-06
- HighWOM Aquilex Fluid Control System Bag Deflector Recalled for Pump Deficit Error
FDA (Devices) · 2019-10-09
Same hazard · packaging damage
See all →- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
- HighCatheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
- HighDental implants recalled after import under non compliant temperature and storage conditions
FDA (Devices) · 2025-10-08