Food, drugs, devices › Stradis Medical, LLC dba Stradis Healthcare
Device recall: NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
Stradis Medical, LLC dba Stradis Healthcare (Peachtree Corners, GA) initiated this device recall on 25 Jul 2022; FDA lists 3 product records under event 90668, classified Class II.
FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Stradis Medical, LLC dba Stradis Healthcare has 5 enforcement events on this register, with a median of 5 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA.
Reason for recall
"The sterile barrier may be compromised."
Distribution
"US Nationwide distribution in the state of SC."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1552-2022 | NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697 | 50 units | Class II | Ongoing | 24 Aug 2022 |
| Z-1553-2022 | NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700 | 825 units | Class II | Ongoing | 24 Aug 2022 |
| Z-1554-2022 | NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701 | 850 units | Class II | Ongoing | 24 Aug 2022 |
Context
Other enforcement events for Stradis Medical, LLC dba Stradis Healthcare
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Nov 2022 | STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431 | Device | Class II | 78 |
| 25 Feb 2022 | Surgicare Neuro Pack - Neurological Kit | Device | Class II | 5 |
| 28 Oct 2021 | Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk | Device | Class II | 1 |
| 10 Sep 2021 | Tenaculum, Plastic | Device | Class II | 6 |
All 5 events for Stradis Medical, LLC dba Stradis Healthcare
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The sterile barrier may be compromised."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the state of SC."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.