ACS THAR35BRecalls & reported problems
American Contract Systems, Inc. · ARTHROSCOPY PACK · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Nov 29, 2023Open, Classified
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
Z-0833-2024 · Root cause: Process control · Recall details · FDA record ↗
Other Orthopedic tray devices
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- Medline Industries, Inc. DYNJ17452SMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ902473LMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ900718CMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. CDS780119VMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ21826RMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ906893DMedline Industries, Inc. · Orthopedic tray4 recalls2 reports
- Medline Industries, Inc. DYNJ909505AMedline Industries, Inc. · Orthopedic tray4 recalls1 report
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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