Sapi Med Anoscopes (Adler MicroMed) – Sterility Falsification (2021)
Sterility issues may potentially expose patients to contamination risks.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 R
Brand
Adler MicroMed, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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;
Adler MicroMed, Inc. is recalling Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/ due to Due to issue with product sterility. Sterilization service provider had falsified records.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to issue with product sterility. Sterilization service provider had falsified records.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IL, MA, PA
Page updated: Jan 10, 2026