Exact Medical Probe Cover 6x48" Ultrasonic Transducer Cover Recall: No 510k for body use

Take action

Contact the company & request your remedy

Recalling firmExact Medical Manufacturing, Inc.4917 William St Ste C, N/A · Lancaster, NY 14086-3200

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Exact Medical is recalling their 6"x48" Ultrasonic Transducer Cover (Item ID SH29) because it lacks FDA 510(k) clearance for use in natural or surgical body openings. This means the cover could pose a risk if used medically without proper regulatory approval.

Why it’s dangerous

The product lacks FDA 510(k) clearance, meaning it has not been approved for use in natural or surgical body openings. Without this clearance, the cover could cause injury if used in medical procedures where it might interact with body tissues or openings.

Who’s affected

Medical professionals using this cover for procedures involving body openings may be affected. Patients receiving such procedures with this cover are at risk if the cover is used without proper clearance.

How to tell if you have this one

Check for the Item ID SH29 on the cover. Affected units have lot numbers: 1910E448, 2009E249, 2009E248, 2010E214, or 2011E249.

Brand
Exact Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for Item ID SH29 and the listed lot numbers on the cover to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Why is this cover being recalled?

The cover lacks FDA 510(k) clearance for use in natural or surgical body openings, which means it has not been approved for medical procedures.

What lot numbers are affected?

Lot numbers 1910E448, 2009E249, 2009E248, 2010E214, and 2011E249 are affected.

Is there a fix or remedy for this issue?

The recall record does not specify any remedy or action steps beyond checking product details.

Take action

Contact Exact Medical

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

✉️ Open in email

Subject: Recall Z-1922-2021 — Exact Medical Exact Medical

Hello,

I own a Exact Medical that is covered by recall Z-1922-2021 from Exact Medical.

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-1922-2021 (April 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1922-2021 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.

Exact Medical Manufacturing, Inc. recalls Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29

Recall notice