ACS BFLE56XRecalls & reported problems
American Contract Systems, Inc. · LOWER EXTREMITY - 247542 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name 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
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 15, 2024Open, Classified
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Z-2275-2024 · Root cause: Under Investigation by firm · FDA record ↗
- May 15, 2024Open, Classified
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Z-2277-2024 · Root cause: Under Investigation by firm · FDA record ↗
Other Orthopedic tray devices
- Medline Industries, Inc. CDS780119VMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ902473LMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ905330BMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ17452SMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ21826RMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ900718CMedline 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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