Sterile Colorectal Anoscopes and Proctoscopes Recalled Due to Falsified Sterilization Records
Adler MicroMed recalls 1,858 sterile colorectal anoscopes and proctoscopes due to falsified sterilization records by the service provider, raising concerns about product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for non-sterile medical devices due to falsified sterilization records. While no illnesses or injuries have been reported, non-sterile colorectal medical devices pose a direct risk of infection to patients, making this a high-severity risk-of-harm situation.
Plain-English summary
Adler MicroMed, Inc. is recalling 1,858 Sapi Med sterile disposable colorectal anoscopes and proctoscopes. The recalled devices include multiple models: THE BEAK surgical proctoscope (REF A.4083), THE BEAK diagnostic proctoscope (REF A.4084), the MPR Short multi-purpose rectoscope (REF A.4519), the MPR multi-purpose rectoscope (REF A.4522), and the EPOFLIER surgical kit (REF A.4086).
The recall was issued because the sterilization service provider falsified sterilization records. This means the devices may not have undergone proper sterilization and cannot be confirmed as sterile.
The recalled devices were distributed to healthcare facilities in Florida, Illinois, Massachusetts, and Pennsylvania. Specific lot numbers and sterilization batch numbers are identified in the FDA recall documentation.
Anyone with these products should refer to the FDA notice for detailed information about affected lot numbers and sterilization batch numbers, and should contact Adler MicroMed or the FDA with any questions or concerns.
The recalled product
- 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…
- Manufacturer
- Adler MicroMed, Inc.
- Affected units
- 1,858
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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