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Use caution Medical device recall · FDA · Published July 30, 2018

Civco Needle Guide Recall: Missing Adhesive Risk

Civco recalls 24 sterile needle guides (REF 676-150) due to missing or weak adhesive causing assembly failure. Affected units have specific lot numbers and UDI.

🇺🇸 FDA recall #Z-2947-2018Medical deviceCivco ›
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Recalling firmCivco Medical Instruments Co. Inc.102 1st St S · Kalona, IA 52247-9589
✎ GovInfoNow plain-language explainer

What happened, in plain English

Civco is recalling 24 sterile needle guides that may have missing or insufficient adhesive, which could cause the cannula to detach during use. This poses a risk of injury if the needle guide becomes unstable while being used. Read more at govinfonow.com/recall/70277-civco-needle-guide-recall-missing-adhesive-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/70277-civco-needle-guide-recall-missing-adhesive-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2947-2018

Cite this page

“Civco Needle Guide Recall: Missing Adhesive Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70277-civco-needle-guide-recall-missing-adhesive-risk. Based on FDA recall #Z-2947-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2947-2018%22&limit=1).

Why it’s dangerous

The needle guides may have missing or inadequate adhesive, causing the cannula to detach from the guide during use. This could lead to injury if the detached cannula moves unexpectedly.

Who’s affected

Medical professionals using the needle guides for procedures are most at risk. Patients receiving these devices during medical treatments could be affected if the device fails.

How to tell if you have this one

Check for the product name 'Civco Needle Guide', model REF 6:676-150, and lot numbers A035054 or A042207. The unique device identifier (UDI) is 00841436107334.

  • Brand
    Civco
  • Category
    Medical device
FDA recall event · 2 products

All 2 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
    United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
Recall numberProduct, codes & lotsQuantity
Z-2946-2018CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO; UDI 00841436107327, Lot numbers: A018067, A018067, A021026, A021026, A021226, A021226, A021226, A022447, A022447, A023876, A023876, A025137, A025137, A025137, A025137, A02560, A025606, A025606, A025606, A026609, A026609, A026609, A026609, A026610, A026610, A026610, A028159, A028159, A028645, A029293, A029293, A029293, A029383, A032036, A032036, A032036, A032036, A032036, A032036, A033139, A033139, A033139, A033139, A033153, A033153, A035009, A035009, A035009, A035010, A035010, A035010, A035010, A035010, A035568, A035568, A037150, A037231, A037231, A037231, A037585, A037585, A039417, A039417, A040376, A040376, A040839, A041444, A041444, A041444, A041723, A041723107 units
Z-2947-2018CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO; UDI 00841436107334, Lot numbers: A035054, A0422073 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Condition

    Inspect the needle guide for signs of missing or weak adhesive holding the cannula in place.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Jul 30, 201812. FDA classified it Class II: Aug 29, 201823. Published in FDA’s Enforcement Report: Sep 5, 201834. FDA terminated the recall: Sep 16, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates the product may have missing or insufficient adhesive, which could cause detachment during use. Do not use until confirmed safe.

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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-2947-2018 (July 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2947-2018 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA