ConMed Recalls Electrosurgical Safety Holsters Due to Compromised Sterile Seals
ConMed is recalling 313,190 electrosurgical safety holsters because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no illnesses or injuries have been reported and the defects were discovered prior to use, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ConMed Corporation is recalling 313,190 units of CONMED(R) Electrosurgical Safety Holsters, REF/Catalog No. 137668. The recall is due to complaints that some devices had broken through the seal of the sterile pouch, and ConMed confirmed that the pouch seals were compromised on the affected products.
The affected lot codes range from 120628X to 120917X. These devices were distributed worldwide, including in the United States, 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.
ConMed states that in no instance has a compromise in the sterile barrier resulted in illness or injury, and the compromised seals were discovered prior to use. The agency classifies this as a Class II recall.
The recalled product
- Product
- CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, 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