CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report
Pdsii¿vio¿¿usp6-0(m0.7)¿d/a¿c recalled by Ethicon Endo Surgery
Ethicon Endo Surgery is recalling Pdsii¿vio¿¿usp6-0(m0.7)¿d/a¿c-1, distributed nationwide in the US. The recall was initiated on 7 Mar 2025 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-1514-2025
- FDA event ID
- 96461
- Recalling firm
- Ethicon Endo Surgery, Guaynabo, PR
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Mar 2025
- FDA classified
- 3 Apr 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Mar 2025 | Recall initiated by company | |
| 3 Apr 2025 | Classified by FDA | +27 days |
| 9 Apr 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Identified curing issues with the silicone during the needles manufacturing process.
Product as listed by the FDA
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Where it was distributed
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
Questions about this recall
Why was it recalled?
Identified curing issues with the silicone during the needles manufacturing process.
Which lots are affected?
Product Code: Z127H-50; GMDN: 16584; UDI-DI: 10705031060227; Lot number: 104BQC;
Where was it sold?
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 96461This product is part of a recall event; the main page for the event is Pds¿plus¿vio¿¿usp6-0(m0.7)¿d/a¿c-1¿mp recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pds¿plus¿vio¿¿usp6-0(m0.7)¿d/a¿c-1¿mp recalled | Ethicon Endo Surgery | Other | Nationwide | |
| CLASS II | Prolene Blu Usp6-0(m0.7) S/a P-1 Prm recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide | |
| CLASS II | Ethibond Excel Grn Usp2-0(m3) D/a Mh recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
More recalls from Ethicon Endo Surgery
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Echelon Linear Cutters Reload Blue, intended recalled | Ethicon Endo-Surgery | Other | OH |
| Device | CLASS I | Endopath Echelon Vascular White Reload recalled by Ethicon Endo-Surgery | Ethicon Endo-Surgery | Other | Nationwide |
| Device | CLASS II | Ethibond Excel Grn Usp2-0(m3) D/a Mh recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
| Device | CLASS II | Prolene Blu Usp6-0(m0.7) S/a P-1 Prm recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
| Device | CLASS II | Pds¿plus¿vio¿¿usp6-0(m0.7)¿d/a¿c-1¿mp recalled | Ethicon Endo Surgery | Other | Nationwide |
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