AVANOS 181A321Recalls & reported problems
Avanos Medical, Inc. · AVANOS* Universal Block Trays · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193493997947), received between Aug 28, 2020 and May 5, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination 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.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Delivered as Unsterile Product1
- Device Markings/Labelling Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2022Device Markings/Labelling Problem
ALL AVANOS UNIVERSAL BLOCK TRAYS MISSING 1-LBL FOR NKT PRODUCTS. ALL OF LOT 30175885 AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14287856 ↗MalfunctionJun 25, 2021Contamination /Decontamination Problem; Material Integrity Problem
SMALL PIECE OF UNKNOWN DEBRIS FOUND WITHIN A DEPRESSION OF A "UNIVERSAL BLOCK TRAY". TRAY AND STERILE FIELD REPLACED, "CONTAMINATED TRAY" REMOVED, PHOTOGRAPHED AND PARTICLE ATTACHED TO THE PACKAGING FROM WHICH IT WAS REMOVED. PRODUCT NAME: UNIVERSAL BLOCK TRAY. TRAY AND CONTENTS DISCARDED; SAVED OUTER PACKAGING AND UNKNOWN DEBRIS (TAPED TO PACKAGING).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12066205 ↗MalfunctionAug 28, 2020Delivered as Unsterile Product
STERILITY ISSUE: AFTER OPENING AVANOS UNIVERSAL BLOCK TRAY REF#(B)(4) LOT#20023460 EXP. 2022-06-01; A BLACK HAIR WAS DISCOVERED IN PACK. PACK REMOVED AND NEW SET UP BEGAN PRIOR TO PATIENT ENTERING OPERATING ROOM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10464862 ↗
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- BD Luer-Lok, BD Glaspak 405672Becton, Dickinson And Company · Anesthesia conduction kit1 recall27 reports
- BD Luer-Lok, BD Glaspak 405673Becton, Dickinson And Company · Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Becton, Dickinson And Company · Anesthesia conduction kit1 recall7 reports
- BD Luer-Lok, BD Glaspak 405707Becton, Dickinson And Company · Anesthesia conduction kit1 recall4 reports
- BD Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405735Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.