Z-1901-2021Class II

Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK...

Name: Z-1901-2021 Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK...
Creator: Adler MicroMed, Inc.
Published: 2021-04-23
License: https://open.fda.gov/license/

Adler MicroMed, Inc. / initiated 2021-04-23 / Terminated / root cause: manufacturing process

FDA source

Adler MicroMed, Inc. began a recall of Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile... on 2021-04-23. FDA classified it as Class II and gives the reason as "Due to issue with product sterility. Sterilization service provider had falsified records". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1901-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-23
Posted: 2021-06-21
Terminated: 2022-10-04
Recalling firm: Adler MicroMed, Inc.
Product: 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
Product code: KDM Sigmoidoscope, Rigid, Non-Electrical
Reason for recall: Due to issue with product sterility. Sterilization service provider had falsified records.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 04/23/2021, the Recalling Firm communicated an URGENT: MEDICAL RECALL message via a telephone calls to customers and followed up email with a notification letter, informing them that the affected products that are labeled as sterile may not be sterile and the products could affect the sterile field and cause patient infections. Customers are instructed to: 1) Segregate and quarantine the affected products and wait for further instructions for disposition to follow, and 2) Complete and return the attached Acknowledgement and Receipt Form and indicate the quantities and location of the recalled products.
Quantity in commerce: 1,858 devices
Distribution: US distribution: FL, IL, MA, and PA.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1901-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1901-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21

Product code KDM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)