Olsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk
Olsen Medical is recalling 4,110 Symmetry monopolar forceps worldwide because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.
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 risk-of-harm product (compromised sterile seal) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Olsen Medical is recalling 4,110 units of Symmetry Olsen monopolar forceps. The affected products include Insulated Potts-Smith Forceps, Insulated Bayonet Forceps with Serrated Tips, and Insulated Bayonet Forceps with Cathedral Tips. The recall covers all codes and involves worldwide distribution.
The recall is being issued because the products may encroach into the sterile pouch seal, thereby increasing the risk of the seal being compromised. This defect could potentially affect the sterility of the medical devices.
Healthcare facilities and distributors should stop using the affected forceps and contact Olsen Medical for further instructions on the recall process.
The recalled product
- Product
- Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF…
- Manufacturer
- Olsen Medical
- Hazard
- Affected units
- 4,110
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)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Olsen Medical 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 5 products in this recall →Related recalls
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