Exact Medical: Ultrasonic Transducer Cover Recall - No 510k for Body Use

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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 ultrasonic transducer covers that were not cleared for use in natural or surgical body openings. This poses a risk of injury if used improperly in medical procedures.

Why it’s dangerous

The product lacks 510k clearance, meaning it was not approved for use in body openings. This could lead to injury if the cover is used during medical procedures without proper safety validation.

Who’s affected

Medical professionals using these covers during procedures are most at risk. Patients receiving treatments with these covers could face injury if the product is used without proper clearance.

How to tell if you have this one

Check for Item ID 1006664 with lot numbers 2002E015 or 2011E316 on the covers. These covers are sold by Exact Medical for medical use.

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 1006664 and lot numbers 2002E015 or 2011E316 on the covers.

✎ GovInfoNow

Questions people ask

Is there a remedy for this recall?

The recall notice does not specify a remedy.

What is the hazard with these covers?

The covers lack 510k clearance for use in natural or surgical body openings, which could cause injury if used improperly.

Which lot numbers are affected?

Lot numbers 2002E015 and 2011E316.

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-1924-2021 — Exact Medical Exact Medical

Hello,

I own a Exact Medical that is covered by recall Z-1924-2021 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.

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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-1924-2021 (April 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1924-2021 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, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664

Recall notice