CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
1 Stratafix" Spiral PDS Plus Violet 36" CTX Needle, SXPP1B402 recalled
Ethicon is recalling 1 Stratafix" Spiral PDS Plus Violet 36" CTX Needle, SXPP1B402, distributed nationwide in the US. The recall was initiated on 28 Aug 2019 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-1335-2020
- FDA event ID
- 84772
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2019
- FDA classified
- 20 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 28 Aug 2019 | Recall initiated by company | |
| 20 Feb 2020 | Classified by FDA | +176 days |
| 26 Feb 2020 | 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
The product do not meet certain internal testing specifications.
Product as listed by the FDA
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
Where it was distributed
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
Questions about this recall
Is 1 Stratafix" Spiral PDS Plus Violet 36" CTX Needle, SXPP1B402 recalled?
Yes. Ethicon recalled 1 Stratafix" Spiral PDS Plus Violet 36" CTX Needle, SXPP1B402 on 28 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-1335-2020.
Why was it recalled?
The product do not meet certain internal testing specifications.
Which lots are affected?
GTIN: 10705031236059 Lot Numbers: PAH073, PAH054 Expiration Date: 12/31/2020
Where was it sold?
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
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.
More recalls from Ethicon
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled | Ethicon | Other | Nationwide |
| Device | CLASS II | Perma-hand Silk Suture recalled by Ethicon | Ethicon | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Ethibond Excel Polyester Suture recalled by Ethicon | Ethicon | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Prolene Polypropylene Suture recalled by Ethicon | Ethicon | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Monocryl" (poliglecaprone Suture recalled by Ethicon | Ethicon | Packaging Defects | 45 states |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |