Alcon Single-Use Iris Bipolar Forceps Recalled for Lack of Sterilization
Alcon Research, Ltd. is recalling single-use iris bipolar forceps labeled as sterile but not sterilized prior to shipment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 medical device that was not sterilized as labeled, creating a risk of infection or harm during surgery. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research, Ltd. is recalling 2,321 units of Single-Use Curved Jewelers/Iris Bipolar Forceps (REF 8065129101) and Single-Use Straight/Iris Bipolar Forceps (REF 8065129501). These electrosurgical instruments are used in ophthalmic surgery and are labeled as ethylene oxide (EO) sterilized. The recall is due to the fact that the units were not sterilized prior to shipment to customers.
The affected products are identified by lot numbers 061814-95 and 080614-91. The products were distributed worldwide, including the United States (nationwide) and Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.
Healthcare providers and patients should stop using these specific forceps immediately. Users should contact Alcon Research, Ltd. for instructions on returning the products or obtaining replacements.
The recalled product
- Product
- Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 2,321
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)
- Lot numbers 061814-95 and 080614-91
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Alcon Research, Ltd.
See all →- SevereInfinity FMS Pak surgical device recalled for plastic debris hazard
FDA (Devices) · 2023-08-23
- SeverePhaco Standalone Tips Recalled Due to Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereLegion FMS Pak Surgical Instruments Recalled for Patient Injury from Plastic Debris
FDA (Devices) · 2023-08-23
- SevereAlcon Constellation Procedure Pak recalled due to plastic debris risk
FDA (Devices) · 2023-08-23
- HighCenturion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris
FDA (Devices) · 2023-08-23
Same hazard · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateStingray Surgical Recalls Bipolar Forceps Due to Uncleared Instructions
FDA (Devices) · 2012-07-25
- ModerateStryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateGyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure
FDA (Devices) · 2013-08-28
- ModerateStryker Laparoscopic Forceps Recalled Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker Laparoscopic Forceps Recalled Due to Sterilization Parameter Errors
FDA (Devices) · 2014-12-24
- ModerateStryker Laparoscopic Forceps Recalled Due to Sterilization Instructions Error
FDA (Devices) · 2014-12-24