ACS PLBY52ERecalls & reported problems
American Contract Systems, Inc. · CYSTO PACK · Class 2
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
- Sep 4, 2025Open, Classified
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Z-0174-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Endoscope introducer kit devices
- Medline Industries, Inc. DYNJ58648JMedline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- ACS BUCY78EAmerican Contract Systems, Inc. · Endoscope introducer kit2 recalls0 reports
- Medline Industries, Inc. DYNJ44673GMedline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- Medline Industries, Inc. DYNJ66447Medline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- Merit Medical® 00884450360408Merit Medical Systems, Inc. · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH SEN15SERM5Cardinal Health 200, LLC · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH PGVMDVB26Cardinal Health 200, LLC · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH SBA73CLK26Cardinal Health 200, LLC · Endoscope introducer kit1 recall0 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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page