Dutch Ophthalmic: 25-Gauge Infusion Line Recall - Risk of Wrong Gauge
Dutch Ophthalmic USA recalls 25-gauge surgical packs containing 23-gauge infusion lines. This mismatch risks incorrect surgical use. Affected units have specific product numbers and lot codes.
Lower-risk recall
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Contact the company
What happened, in plain English
Dutch Ophthalmic USA recalls surgical packs that include a 23-gauge infusion line instead of the intended 25-gauge. Using these packs with the wrong gauge could cause incorrect surgical procedures. Read more at govinfonow.com/recall/67887-dutch-ophthalmic-25-gauge-infusion-line-recall-risk-of-wrong.
Source Summary by GovInfoNow · govinfonow.com/recall/67887-dutch-ophthalmic-25-gauge-infusion-line-recall-risk-of-wrong · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2252-2021
Cite this page
“Dutch Ophthalmic: 25-Gauge Infusion Line Recall - Risk of Wrong Gauge.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67887-dutch-ophthalmic-25-gauge-infusion-line-recall-risk-of-wrong. Based on FDA recall #Z-2252-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2252-2021%22&limit=1).
Why it’s dangerous
The surgical packs contain a 23-gauge infusion line instead of the labeled 25-gauge. This mismatch could lead to using the wrong gauge during eye surgery, potentially causing complications.
Who’s affected
Surgical teams using the TDC Vitrectomy Pack VGPC 25g surgical packs with product number 8525.201 and lot number 2000401997 are most at risk.
How to tell if you have this one
Check for product number 8525.201 and lot number 2000401997 on the surgical pack. The pack is labeled TDC Vitrectomy Pack VGPC 25g.
- Brand
Dutch Ophthalmic- Category
Medical device
What to do — step by step
Check Product Details
Verify the product number (8525.201) and lot number (2000401997) on the surgical pack.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “US Nationwide Distribution in the states of AL, CA, CO, FL, MI” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Michigan.
Recall timeline
FDA published this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-2252-2021 (May 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2252-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.