Ethicon Recalls Spiral PDS Plus Violet Needles: Testing Failure
Ethicon recalls 1 STRATAFIX Spiral PDS Plus Violet 18" OS-6 needles (lot PAH360) due to not meeting internal testing specs. No remedy stated in official notice.
Recall notice
The product do not meet certain internal testing specifications.
Contact the company
What happened, in plain English
Ethicon is recalling a specific type of surgical needle because it failed internal testing. This means the product may not work as intended during medical procedures, potentially causing complications. Read more at govinfonow.com/recall/67092-ethicon-recalls-spiral-pds-plus-violet-needles-testing-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/67092-ethicon-recalls-spiral-pds-plus-violet-needles-testing-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1334-2020
Cite this page
“Ethicon Recalls Spiral PDS Plus Violet Needles: Testing Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67092-ethicon-recalls-spiral-pds-plus-violet-needles-testing-failure. Based on FDA recall #Z-1334-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1334-2020%22&limit=1).
Why it’s dangerous
The needle failed internal testing specifications, which could mean it doesn't function properly during surgery. This might lead to complications like improper tissue sealing or other surgical issues.
Who’s affected
Surgical staff and hospitals that purchased the recalled needle model (SXPP1B201) from the manufacturer. Patients using this needle during procedures may be at risk if the product fails.
How to tell if you have this one
Check for the model number SXPP1B201 on the needle packaging. The lot number PAH360 and expiration date 12/31/2020 are also associated with this recall.
- Brand
Ethicon- Product
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1334-2020 | 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201; GTIN: 10705031235861 Lot Number: PAH360 Expiration Date: 12/31/2020 | 3 units |
| Z-1335-2020 | 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402; GTIN: 10705031236059 Lot Numbers: PAH073, PAH054 Expiration Date: 12/31/2020 | 660 units |
| Z-1336-2020 | 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429; GTIN: 10705031235816 Lot Number: PAH166 Expiration Date: 12/31/2020 | 133 units |
What to do — step by step
Check Product Details
Look for the model number SXPP1B201 and lot number PAH360 on the needle packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1334-2020 (August 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1334-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.