Sun Med STAT-Check Resuscitator Recall: Patient Port Detachment Risk

Take action

Contact the company & request your remedy

Recalling firmSun Med, LLC2710 Northridge Dr NW Ste A, N/A · Grand Rapids, MI 49544-9112

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Sun Med is recalling their STAT-Check manual resuscitator model SC9200MBP-1 with specific lot numbers because the patient port could detach during use, potentially failing to deliver air to patients. This is a serious hazard for medical professionals using the device in emergency situations.

Why it’s dangerous

The patient port retaining ring may not fully secure, causing the port to detach during use. This could interrupt air delivery to patients, which is critical in emergency medical situations where continuous ventilation is needed.

Who’s affected

Healthcare providers using the STAT-Check manual resuscitator model SC9200MBP-1 with lot numbers 313406, 313447, 313164, 313165, or 313166 are most at risk. This recall affects medical devices used in emergency care settings.

How to tell if you have this one

Check the product label for lot numbers: 313406, 313447, 313164, 313165, or 313166. The device is a manual resuscitator/ventilator model SC9200MBP-1 manufactured by Sun Med, LLC.

Brand
Sun Med
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for lot numbers on the device label: 313406, 313447, 313164, 313165, or 313166.
Contact Manufacturer
Reach out to Sun Med, LLC for guidance on next steps if you have the recalled lot numbers.

✎ GovInfoNow

Questions people ask

What lot numbers are affected?

Lot numbers 313406, 313447, 313164, 313165, and 313166.

Why is this device being recalled?

The patient port retaining ring may not fully seat, causing the port to detach during use and potentially interrupting air delivery to patients.

What should I do if I have the recalled device?

Check the device label for the lot number. If it matches the affected numbers, contact Sun Med, LLC for guidance.

Take action

Contact Sun Med

We’ve drafted a message you can send Sun Med to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2145-2018 — Sun Med Sun Med

Hello,

I own a Sun Med that is covered by recall Z-2145-2018 from Sun Med.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2145-2018 (May 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2145-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.

Sun Med, LLC recalls STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1

Use caution until it’s fixed