McKesson 73-OPA28Recalls & reported problems
Mckesson Medical-Surgical Inc. · McKesson OPA/28 HLD · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10612479185989), received between Apr 24, 2025 and May 15, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Use of Device Problem1
Patient problems
- Hypersensitivity/Allergic reaction4
- Anaphylactoid / Anaphylaxis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Use of Device Problem
THE USER FACILITY REPORTED THAT FIVE DIFFERENT PATIENTS EXPERIENCED ALLERGY SYMPTOMS FOLLOWING PROCEDURES WHICH INCLUDED USE OF CYSTOSCOPES REPROCESSED USING MCKESSON OPA/28 HLD. THE PATIENTS SOUGHT ADDITIONAL MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN IF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 25183096 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
DEALER REPORTED THAT BETWEEN 2023 AND 2025 AFTER A CYSTOSCOPY PROCEDURE A PATIENTS EXPERIENCED 5 EPISODE OF ALLERGY AND ANAPHYLAXIS OF WHICH TWO OF THEM RESULTED IN A TRIP TO THE ER.
Patient problems: Anaphylactoid / Anaphylaxis; Hypersensitivity/Allergic reaction
MAUDE report 25176804 ↗MalfunctionMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THREE DIFFERENT PATIENTS EXPERIENCED AN ALLERGIC REACTION AFTER BEING EXPOSED TO MCKESSON OPA/28 HLD. THE PATIENTS RECEIVED ADDITIONAL MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21941456 ↗InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEALER/DISTRIBUTOR REPORTED ALLERGIC REACTIONS OCCURING IN 3 PATIENTS ON SEPARATE OCCASION'S.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21900722 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.