ModerateClass IITerminated

FDA Devices recall · Reported June 30, 2021

Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Pu

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1901-2021.

Q: Where was the recalled product distributed?

Distribution: US distribution: FL, IL, MA, and PA..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1901-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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

Recall #: Z-1901-2021
Affected scope: 1,858 devices
Initiated: April 23, 2021

Compiled from official public sources by the editorial team. · Updated July 2026

Verify with FDA Devices →

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Adler MicroMed, Inc. recalled Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Descrip… - a moderate-severity action.

Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Descrip… was recalled by Adler MicroMed, Inc. in June 30, 2021. Reason: Due to issue with product sterility. Sterilization service provider had falsified records.. Check the official notice for the remedy. Verify recall #Z-1901-2021 with the FDA Devices before acting.

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The recall

Adler MicroMed, Inc. issued this moderate-severity FDA Devices recall-Due to issue with product sterility. Sterilization service provider had falsified records..

Moderate
severity level: 2K units
affected scope: Class II
classification: June 30, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1901-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1901-2021) was formally reported on June 30, 2021, with the manufacturer initiating the action on April 23, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Adler MicroMed, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 1,858 devices.

The documented reason for this recall is: Due to issue with product sterility. Sterilization service provider had falsified records. Distribution data in the federal record shows the product reached: US distribution: FL, IL, MA, and PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

1,858 devices

Related Recalls

3 from same agency

Product description

Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable

Reason for recall

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1901-2021
Date reported	June 30, 2021
Date initiated	April 23, 2021
Recalling firm	Adler MicroMed, Inc.
Firm location	San Diego, CA
Affected scope	1,858 devices
Distribution	US distribution: FL, IL, MA, and PA.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1,858 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1901-2021) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1901-2021.

Where was the recalled product distributed? ▼

Distribution: US distribution: FL, IL, MA, and PA..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1901-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 30, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.