Surgical Instrument Service And Savings Recalls 13 Medical Devices Due to Seal Compromise
Surgical Instrument Service And Savings, Inc. is recalling 13 medical devices because compromised seals may allow products to fall out of sterile pouches.
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 2/5 (Moderate).
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, and the hazard involves a potential loss of sterility without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 13 medical devices, including endoscopic linear cutters, clip appliers, and skin staplers. The recall involves specific lots of these instruments, such as the ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter and the Ligaclip MCA Multiple Clip Applier.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising sterility.
The affected devices were distributed nationwide. Consumers and healthcare providers should stop using these specific lots and contact the recalling firm for further instructions.
The recalled product
- Product
- -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W.…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 13
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 (7)
- 122300
- 123263
- 122490
- 122753
- 122406
- 122675
- 122309
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.
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