FDA Medical Device Recalls (openFDA)
Adler MicroMed, Inc.: 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
- Recall number
- Z-1901-2021
- 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
- Status
- Terminated
- Initiated
- 2021-04-23
- Posted
- not on file
- Terminated
- 2022-10-04
- Reason
- Due to issue with product sterility. Sterilization service provider had falsified records.
- 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
- 1,858 devices
- Distribution
- US distribution: FL, IL, MA, and PA.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K070913","K070915"]
- PMA numbers
- not on file
- Product code
- KDM
- Firm FEI
- 3011412640
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28