ConMed Recalls ABC Nozzles Due to Compromised Sterile Pouch Seals
ConMed is recalling 313,190 ABC Nozzles because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (compromised sterile barrier) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
ConMed Corporation is recalling 313,190 units of the ABC(R) NOZZLE, Single Patient Use Nozzle (REF/Catalog No. 130343). These sterile, prescription-only devices are intended for use with the 130500 Reusable ABC(R) Handpiece. The recall covers units with lot codes ranging from 120628X to 120917X.
The recall was initiated after ConMed received complaints that some devices had broken through the seal of the sterile pouch. The company confirmed that the pouch seals were compromised on the affected products. The compromised seals were discovered prior to use. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury.
The affected devices were distributed nationwide in the United States, in Puerto Rico, and internationally to Belgium, Colombia, the Czech Republic, Dubai, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay. Healthcare providers should stop using the affected devices and contact ConMed for instructions on return or replacement.
The recalled product
- Product
- ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
- Manufacturer
- ConMed Corporation
- Affected units
- 313,190
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 (9)
- Beginning Lot Code 120628X
- 09 represents the month (September)
- 17 represents the day of the month
- and X represents the manufacturing shift code (1
- 2
- 3
- 4
- 5
- 6 or 9)].
Distribution
Part of a larger recall action
This product is one of 20 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
Same manufacturer · ConMed Corporation
See all →- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- HighConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
Same hazard · sterile barrier compromise
See all →- HighBARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- ModerateDisposable Mixing Bowls with Spatula recalled for compromised sterile barrier
FDA (Devices) · 2026-05-06
- SevereTufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
FDA (Devices) · 2025-05-21
- HighIntroducer Needle REF NDL-107-04 Sterile Packaging Recall
FDA (Devices) · 2025-05-14
- HighGalt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue
FDA (Devices) · 2025-05-14