CLASS II Device recall · Reported 17 May 2023 · FDA Enforcement Report
M-Close Kit recalled by New Wave Endo-Surgical
New Wave Endo-Surgical is recalling M-Close Kit, distributed nationwide in the US. The recall was initiated on 8 Jul 2020 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-1570-2023
- FDA event ID
- 92005
- Recalling firm
- New Wave Endo-Surgical, Coconut Creek, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jul 2020
- FDA classified
- 9 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 8 Jul 2020 | Recall initiated by company | |
| 9 May 2023 | Classified by FDA | +1035 days |
| 17 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The plastic housing on the device may fracture
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Where it was distributed
US Nationwide distribution in the states of FL, MA, and GA.
Questions about this recall
Is M-Close Kit recalled?
Yes. New Wave Endo-Surgical recalled M-Close Kit on 8 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-1570-2023.
Why was it recalled?
The plastic housing on the device may fracture
Which lots are affected?
UDI/DI: 00850009417022, Lot code C2020
Where was it sold?
US Nationwide distribution in the states of FL, MA, and GA.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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