STANDARD TEXTILE CO., INC.
10 inspections · 3 clearances · 2 compliance actions · 1 adverse events · aggregated across 2 source records
Scorecard
Events per device across the 1,095-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
1,095 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Barrier Supreme Surgical Drape | 96601092 | PUI | 00634916186697 | 0 |
| Barrier Supreme Surgical Drape Sheet | 95674375 | PUI | 00634916005417 | 0 |
| T-180 Drape Sheet | 95280212 | PUI | 00634916005349 | 0 |
| BACK VEST PRECAUTION GOWN | 66147015 | OEA | 00634916068597 | 0 |
| Barrier Supreme Drape | 95500074 | PUI | 00634916059601 | 0 |
| Barrier Supreme Drape | 95500104 | PUI | 00634916059861 | 0 |
| Barrier Supreme Drape | 95500084 | PUI | 00634916059618 | 0 |
| Barrier Supreme Drape | 95500064 | PUI | 00634916059595 | 0 |
| Barrier Supreme Drape | 95589984 | PUI | 00634916054958 | 0 |
| Barrier Supreme Drape | 96601662 | PUI | 00634916354812 | 0 |
| Barrier Supreme Drape | 95500094 | PUI | 00634916059748 | 0 |
| Barrier Supreme Eye Drape | 96801654 | PUI | 00634916352641 | 0 |
| Barrier Supreme Surgical Drape | 226H1322 | PUI | 00634916171396 | 0 |
| Barrier Supreme Surgical Drape | 95688295 | PUI | 00634916008272 | 0 |
| Barrier Supreme Surgical Drape | 95600474 | PUI | 00634916098099 | 0 |
| Barrier Supreme Surgical Drape | 96301112 | PUI | 00634916190564 | 0 |
| Barrier Supreme Surgical Drape | 96301764 | PUI | 00634916708578 | 0 |
| Barrier Supreme Surgical Drape | 96601113 | PUI | 00634916187038 | 0 |
| Barrier Supreme Surgical Drape | 95688744 | PUI | 00634916087895 | 0 |
| Barrier Supreme Surgical Drape | 95688754 | PUI | 00634916087888 | 0 |
| Barrier Supreme Surgical Drape | 95500865 | PUI | 00634916127355 | 0 |
| Barrier Supreme Surgical Drape | 96601022 | PUI | 00634916147018 | 0 |
| Barrier Supreme Surgical Drape | 95682582 | PUI | 00634916005431 | 0 |
| Barrier Supreme Surgical Drape | 96601174 | PUI | 00634916225389 | 0 |
| Barrier Supreme Surgical Drape | 96601152 | PUI | 00634916197440 | 0 |
| Barrier Supreme Surgical Drape | 95688285 | PUI | 00634916183016 | 0 |
| Barrier Supreme Surgical Drape | 95589863 | PUI | 00634916043082 | 0 |
| Barrier Supreme Surgical Drape | 95601622 | PUI | 00634916327731 | 0 |
| Barrier Supreme Surgical Drape | 96660482 | PUI | 00634916016888 | 0 |
| Barrier Supreme Surgical Drape | 95589882 | PUI | 00634916043105 | 0 |
Showing 1–30 of 1,095Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2013-05-07 | WL | Warning Letter | Standard Textile Co Inc |
| 2013-05-07 | WL | Warning Letter | Standard Textile Co Inc |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 1527185 | STANDARD TEXTILE CO., INC. | Cincinnati, OH, US | NAI |