Americot 20-01SRecalls & reported problems
American Surgical Company, LLC · Americot Blue 1/4" x 1/4" · 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.
3 other recalls cover devices cleared under the same FDA submission (K854713); they may or may not involve this specific model.
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 18, 2024Open, Classified
Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.
Z-0287-2025 · Root cause: Process control · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K854713. One submission often covers many models, so check the product and lot details in each record.
- Z-1751-2016 · Mar 31, 2016 · TerminatedAmerican Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Z-1725-2016 · Mar 31, 2016 · TerminatedAmerican Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Z-1726-2016 · Mar 31, 2016 · TerminatedAmerican Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Other Neurosurgical Paddie devices
- CODMAN® 801400Integra Lifesciences Production Corporation · Neurosurgical paddie2 recalls9 reports
- CODMAN® 801407Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall6 reports
- CODMAN® 801451Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall5 reports
- MEDLINE NEUROSPNG05Medline Industries, Inc. · Neurosurgical paddie1 recall5 reports
- CODMAN® 801404Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall4 reports
- CODMAN 80-1407Cerenovus, Inc. · NEUROSURGICAL PADDIE1 recall2 reports
- CODMAN® 801408Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN® 801406Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 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.
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