CLASS II Device recall · Reported 1 Jun 2022 · FDA Enforcement Report
Surgical Suture Kit recalled by Stradis Healthcare
Stradis Healthcare is recalling Surgical Suture Kit, distributed in North Carolina. The recall was initiated on 22 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1132-2022
- FDA event ID
- 90059
- Recalling firm
- Stradis Healthcare, Waukegan, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2022
- FDA classified
- 25 May 2022
- Reported
- 1 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 22 Apr 2022 | Recall initiated by company | |
| 25 May 2022 | Classified by FDA | +33 days |
| 1 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Surgical Suture Kit
Where it was distributed
US Distribution to NC.
Questions about this recall
Why was it recalled?
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Which lots are affected?
Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
Where was it sold?
US Distribution to NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 1 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stradis Healthcare
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|---|---|---|---|---|---|
| Device | CLASS II | Hct Central Line Insertion Tray, I recalled by Stradis Healthcare | Stradis Healthcare | Sterility | Nationwide |
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| Device | CLASS II | Tacy Medical, Inc Port Access Tray, Sterile, Qty recalled | Stradis Healthcare | Sterility | Nationwide |
| Device | CLASS II | Picc Kit, 10/cs, Access Medical Label recalled by Stradis Healthcare | Stradis Healthcare | Sterility | Nationwide |
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Other Surgical Instruments recalls
All 3,816| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical | Wilson-Cook Medical | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |