Surgical Instrument Service And Savings Recalls Reprocessed Medical Devices
Surgical Instrument Service And Savings, Inc. is recalling 34 reprocessed medical devices because the sterile barrier seal became compromised, allowing product to fall out of the pouch.
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 barrier) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 34 units of reprocessed medical devices, including the ACCU-PASS Suture Shuttle, Carpal Tunnel Release Blade Assembly, ENDO-SCRUB 2 Sheath, and Spectrum II Disposable Suture Hook. The recall covers specific lots distributed nationwide.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed devices became compromised. This defect allows the product to fall out of the pouch, potentially compromising sterility.
Consumers and healthcare facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 34
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)
- 123263
- 122504
- 122406
- 122592
- 122482
- 123043
- 122289
- 122518
- 122511.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Surgical Instrument Service And Savings, Inc. 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 22 products in this recall →Related recalls
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