The Recall Desk
HighFDA (Devices)·Z-1553-2022·Announced 2022-08-24

Surgical forceps recalled due to compromised sterile barrier

Stradis Medical is recalling NARMD MEDICAL DEPOT Kelly Straight forceps because the sterile barrier may be compromised. The recall affects 825 units distributed nationwide in South Carolina.

What this means for you

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 with a potential sterile barrier compromise on surgical forceps. No illnesses, injuries, or hospitalizations have been reported. The hazard represents a risk of infection, fitting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5" (Part Number ZZ-0700) because the sterile barrier may be compromised.

The recall involves 825 units distributed nationwide in South Carolina. The affected lot numbers are 22145487092 and 22154486659, with UDI/DI M752ZZ07000.

Healthcare facilities and medical professionals using these forceps should cease use immediately and contact the manufacturer for instructions regarding inspection or replacement.

The recalled product

Product
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Instruments
Hazard
  • sterile-barrier-compromise
  • infection-risk

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-0700
  • Lots: 22145487092 and 22154486659 UDI/DI: M752ZZ07000

Distribution

Distributed nationwide across the United States.

Related recalls

Same category