Surgical forceps recalled due to potentially compromised sterile barrier
Stradis Medical recalls 850 surgical forceps (NARMD MEDICAL DEPOT Forceps, part ZZ-0701) due to potentially compromised sterile barriers. Healthcare facilities with these units should identify affected lot numbers and contact the manufacturer for guidance.
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: This is an FDA Class II recall for a medical device with a potential risk of infection due to compromised sterility. No illnesses or injuries have been reported. The hazard is theoretical—a risk of harm to patients undergoing surgery—but actual patient harm has not occurred, placing this in the High severity category.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling 850 units of NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5" with part number ZZ-0701. Affected lot numbers are 22027483172 and 22131487071. The product was distributed in the United States.
The recall stems from a potentially compromised sterile barrier on these forceps. Because a compromised sterile barrier may allow bacterial contamination of the surgical instrument, there is a risk of patient infection if the forceps are used in medical procedures.
Healthcare facilities, surgery centers, and others in possession of these forceps should identify affected units using the lot numbers and part number. Contact Stradis Medical, LLC dba Stradis Healthcare for guidance on the recalled units. The unique device identifier (UDI/DI) M752ZZ07010 can be used to identify affected devices.
The recalled product
- Product
- NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 850
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 (2)
- SKU/Part Number: ZZ-0701
- Lots: 22027483172 and 22131487071 UDI/DI: M752ZZ07010
Distribution
Part of a larger recall action
This product is one of 3 recalled by Stradis Medical, LLC dba Stradis Healthcare 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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