Lower risk Medical device recall · FDA · Published April 23, 2021

Adler MicroMed Sapi Med Colorectal Anoscopes Recall: Sterility Risk

Adler MicroMed recalls sterile disposable colorectal anoscopes and proctoscopes due to falsified sterilization records. Affected products include specific models and lot numbers. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1901-2021Medical device Adler MicroMed ›

Lower-risk recall

Due to issue with product sterility. Sterilization service provider had falsified records.

Take action

Contact the company

Recalling firmAdler MicroMed, Inc.6842 Elaine Way · San Diego, CA 92120-3933

✎ GovInfoNow plain-language explainer

Adler MicroMed is recalling sterile disposable colorectal anoscopes and proctoscopes because a sterilization provider falsified records. This could lead to infections if the instruments are not properly sterilized. The recall affects specific models and lot numbers. Read more at govinfonow.com/recall/62739-adler-micromed-sapi-med-colorectal-anoscopes-recall-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62739-adler-micromed-sapi-med-colorectal-anoscopes-recall-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1901-2021

Cite this page

“Adler MicroMed Sapi Med Colorectal Anoscopes Recall: Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62739-adler-micromed-sapi-med-colorectal-anoscopes-recall-sterility-risk. Based on FDA recall #Z-1901-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1901-2021%22&limit=1).

The Food and Drug Administration announced on April 23, 2021, that Adler MicroMed, Inc. voluntarily recalled Sapi Med sterile disposable colorectal anoscopes and proctoscopes due to sterility issues caused by falsified sterilization records.

How to tell if you have it

Brand: Adler MicroMed
Product: Sapi Med sterile disposable colorectal anoscopes and proctoscopes
REF Numbers/Lot Numbers: REF A.4083 /Lot Numbers: 18D004l, 19C010l, 19l018l, 20l027l; REF A.4084/Lot Number: 19l015l; REF A.4519/Lot Numbers: 18l013l, 18l012l, 19D002l, 19F012l; REF A.4522/Lot Numbers: 18G003l, 19K023l; REF A.4086/Lot Number: 18F027l
Sterilization Batch Numbers: 18042311; 18092611; 18071211_1; 19040512; 18073112; 19092713; 19120612; 19063012; 20102212; 19063012
Distribution: US distribution in FL, IL, MA, and PA
Units affected: 1,858 devices

The hazard

The recall is due to an issue with product sterility because the sterilization service provider had falsified records. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show other recent recalls of similar products include Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (2026-01-07), Medline Surgical Packs Recall: Calibration Issues May Impact Sterility (2026-01-07), and Medline Surgical Packs Recall: Calibration Issues May Affect Sterility (2026-01-07).

How to tell if you have this one

Check for the product model numbers: A.4083, A.4084, A.4519, A.4522, or A.4086. Look for specific lot numbers listed in the recall notice, such as 18D004l or 19C010l. The products are sterile, disposable, and used for surgical procedures.

Brand
Adler MicroMed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number and lot number to confirm if your product is affected by the recall.
Contact Manufacturer
Reach out to Adler MicroMed directly for further instructions on handling the recalled items.

Where it went and when

Where it was distributed

Distributed in 4 states.

FDA distribution: “US distribution: FL, IL, MA, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Illinois, Massachusetts, Pennsylvania.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Apr 23, 2021Firm started the recall
Jun 21, 2021FDA classified it Class II
Jun 30, 2021Published in FDA’s Enforcement Report
Oct 4, 2022FDA terminated the recall

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/62739-adler-micromed-sapi-med-colorectal-anoscopes-recall-sterility-risk">Adler MicroMed Sapi Med Colorectal Anoscopes Recall: Sterility Risk (GovInfoNow)</a>

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-1901-2021 (April 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1901-2021 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.