CLASS II Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
A.4083/THE BEAK - Surgical proctoscope recalled by Adler MicroMed
Adler MicroMed is recalling A.4083/THE BEAK - Surgical proctoscope, distributed in Florida, Illinois, Massachusetts, Pennsylvania. The recall was initiated on 23 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1901-2021
- FDA event ID
- 87812
- Recalling firm
- Adler MicroMed, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Apr 2021
- FDA classified
- 21 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 23 Apr 2021 | Recall initiated by company | |
| 21 Jun 2021 | Classified by FDA | +59 days |
| 30 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to issue with product sterility. Sterilization service provider had falsified records.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US distribution: FL, IL, MA, and PA.
Questions about this recall
Is A.4083/THE BEAK - Surgical proctoscope recalled?
Yes. Adler MicroMed recalled A.4083/THE BEAK - Surgical proctoscope on 23 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1901-2021.
Why was it recalled?
Due to issue with product sterility. Sterilization service provider had falsified records.
Which lots are affected?
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;
Where was it sold?
US distribution: FL, IL, MA, and PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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