North American Rescue 10 ga ARS Decompression Needle Recall: Incorrect Instructions
North American Rescue recalls 10 ga ARS Decompression Needle (Part ZZ-0298) due to incorrect Instructions for Use. Affected units include specific lots. Contact for remedy.
Lower-risk recall
The device includes the incorrect Instructions for Use.
Contact the company
What happened, in plain English
North American Rescue is recalling 10 ga ARS Decompression Needles with part number ZZ-029: the product has incorrect Instructions for Use. This could lead to improper use and potential safety issues. Read more at govinfonow.com/recall/61880-north-american-rescue-10-ga-ars-decompression-needle-recall-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/61880-north-american-rescue-10-ga-ars-decompression-needle-recall-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2520-2021
Cite this page
“North American Rescue 10 ga ARS Decompression Needle Recall: Incorrect Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61880-north-american-rescue-10-ga-ars-decompression-needle-recall-incorrect. Based on FDA recall #Z-2520-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2520-2021%22&limit=1).
Why it’s dangerous
The device includes incorrect Instructions for Use, which could lead to improper application. This might result in ineffective or unsafe use of the needle during medical procedures.
Who’s affected
Users of the 10 ga ARS Decompression Needle with part number ZZ-0298 are affected. Medical professionals and individuals using the device for decompression are most at risk.
How to tell if you have this one
Check for part number ZZ-0298 on the needle. Affected units include specific lots: W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ.
- Brand
North American Rescue- Category
Medical device
What to do — step by step
Check Instructions
Review the Instructions for Use to confirm they are correct for the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.4 years 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.
Similar recalls
Other North American Rescue recalls
Latest medical device recalls
Keep exploring
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-2520-2021 (August 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2520-2021 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.