ACS GBSU13FRecalls & reported problems
American Contract Systems, Inc. · SET UP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072210838), received between May 23, 2024 and May 23, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2024Contamination; Contamination
A HAIR WAS FOUND IN THE PROCEDURE PACK ON (B)(6) 2024. THE PROCEDURE WAS A NEUROSPINE CASE. THE HAIR WAS DISCOVERED IN THE OR. THE INCIDENT CONTAMINATED THE SURGICAL FIELD RESULTING IN REPORTED PROCEDURE DELAY. THE COMPLAINT SITE WAS ASKED ADDITIONAL IMPACT QUESTIONS ON (B)(6) 2024, (B)(6) 2024. THE COMPLAINT SITE HAS NOT RESPONDED TO THESE INQUIRIES TO-DATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19387904 ↗
Other General surgery tray devices
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- Halyard MSBM036-03_0012Avid Medical, Inc. · General surgery tray5 recalls0 reports
- Medline Industries, Inc. ACC010690Medline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ0842793FMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ38333DMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
- Medline Industries, Inc. DYNJ50110BMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ908124AMedline Industries, Inc. · General surgery tray4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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