CooperSurgical Retractor System Elastic Stays Recalled for Potential Seal Compromise
CooperSurgical is recalling 18,000 units of Retractor System Elastic Stays because the sterile pouch seal may be compromised, increasing the risk of infection.
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 (infection risk due to compromised sterile seal) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
CooperSurgical, Inc. is recalling 18,000 units of Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG). These sterile, single-use medical devices are used to provide retraction for optimal visualization during various procedures. The recall involves specific lots: 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, and 248871.
The recall was initiated because there is a possibility that the seal of the sterile pouch may be compromised. This defect increases the risk of infection for patients using the devices. The affected products were distributed worldwide, including nationwide in the United States and in several foreign countries such as Australia, Canada, Germany, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected lots immediately. CooperSurgical is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety…
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 18,000
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 (11)
- Lots 244660
- 245964
- 250426
- 251395
- 244667
- 244883
- 244884
- 245603
- 245973
- 246138
- & 248871
Distribution
Related recalls
Same manufacturer · CooperSurgical, Inc.
See all →- SevereCooperSurgical Recalls Neonatal Nasal CPAP Replacement Sets Due to Loose Tubing
FDA (Devices) · 2026-09-30
- SevereCooperSurgical Recalls Infant Nasal CPAP Tubing Due to Loose Connection Risk
FDA (Devices) · 2026-09-30
- HighEndosee system convenience trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighHSG procedure trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighEndosee convenience kits label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateCooperSurgical Dilator/Sound Set Recalled for Potential Sterile Pouch Seal Compromise
FDA (Devices) · 2020-06-03
- HighCooperSurgical Recalls Colpo-Pneumo Occluder Due to Compromised Sterile Pouch Seal
FDA (Devices) · 2018-10-17
- HighApplied Medical Recalls TLC Self Retaining Retractor Systems Due to Sterilization Breach
FDA (Devices) · 2016-05-11
- HighVitriGuard Cryopreservation Storage Device Recalled for Sterility Risk
FDA (Devices) · 2022-05-25
- HighCooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2014-06-18
- HighAtriCure EPi-Sense Guided Coagulation System Recalled for Compromised Sterile Seal
FDA (Devices) · 2019-07-03