STERIS CORPORATION
569 adverse events · 275 recalls · 192 inspections · 185 clearances · 9 compliance actions · aggregated across 8 source records
Scorecard
Events per device across the 16,799-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.011 ▼
182 in the last 12 months
Higher volume than 87% of companies with 10+ devices
Recalls per device
0.001 ▼
10 in the last 12 months
Higher volume than 98% 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
16,799 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| (unnamed) | Sterile Lighthandle Cover | FTA | 00724995150136 | 131 |
| VAPROX | PB011 | MLR | 00724995153090 | 45 |
| STERIS | 5095 Surigical Table | FQO | 00724995195649 | 31 |
| VAPROX | PB007 | MLR | 00724995089160 | 31 |
| STERIS | 4095 Surigical Table | FQO | 00724995195236 | 28 |
| STERIS | 4085 Surgical Table | FQO | 00724995154783 | 25 |
| Prolystica | 1C3308 | FLG | 00724995087517 | 22 |
| Celerity | LCB044 | FRC | 10724995154230 | 21 |
| VAPROX | PB028 | MLR | 00724995089511 | 21 |
| V. Mueller | U-0552 | JOL | 10885403138218 | 20 |
| VERIFY | STEAM Integrating | JOJ | 10724995002098 | 20 |
| HexaLux | HexaLux Ceiling Mount | KZF | 00724995244286 | 18 |
| Snowden-Pencer | 89-6112 | GCJ | 10885403122835 | 17 |
| STERIS | 4095 Surgical Table | FQO | 00724995195281 | 16 |
| Snowden-Pencer | SP8364 | GCJ | 10885403171956 | 15 |
| VERIFY | STEAM Integrating | JOJ | 10724995002104 | 15 |
| HexaLux | HexaLux Ceiling Mount | KZF | 00724995167806 | 14 |
| (unnamed) | LB83 | FTA | 00724995172572 | 14 |
| STERIS | 5095 Surgical Table | FQO | 00724995214074 | 14 |
| RELIANCE | Reliance 6500 | PUP | 00724995229504 | 13 |
| VAPROX | 12 | |||
| (unnamed) | Table Pad | LWG | 00724995163877 | 11 |
| Prolystica | 1C2408 | FLG | 00724995211561 | 11 |
| RELIANCE | Reliance 6500 | PUP | 00724995229511 | 11 |
| STERIS | 5095 Surigical Table | FQO | 00724995195625 | 11 |
| STERIS | 5095 Surigical Table | FQO | 00724995195632 | 11 |
| STERIS | 5095 Surgical Table | FQO | 00724995195700 | 11 |
| STERIS | 4095 Surgical Table | FQO | 00724995195410 | 11 |
| STERIS | 4095 Surgical Table | FQO | 00724995195304 | 11 |
| HarmonyAIR | A-Series Lighting System | FSY | 00724995188467 | 10 |
Showing 1–30 of 16,799Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2015-02-20 | WL | Warning Letter | Key Surgical LLC |
| 2014-05-22 | WL | Warning Letter | Isomedix Operations, Inc. |
| 2012-05-29 | WL | Warning Letter | Albert Browne Ltd. |
| 2011-02-09 | WL | Warning Letter | Steris Corporation |
| 2011-02-09 | WL | Warning Letter | Steris Corporation |
| 2010-09-27 | WL | Warning Letter | Isomedix Operations, Inc. |
| 2010-04-20 | INJ | Injunction | Steris Corporation |
| 2010-04-20 | INJ | Injunction | Steris Corporation |
| 2009-07-31 | WL | Warning Letter | Medivators Inc |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3001168737 | ALBERT BROWNE LTD. | LEICESTER, GB | NAI | |
| 3008776287 | Black Diamond Video, Inc. | Richmond, CA, US | OAI | |
| 3008252486 | ELECTRON BEAM SDN BHD | Port Klang Selangor, MY | VAI | |
| 3031571464 | Herotron E-Beam Service GmbH | Bitterfeld Saxony-Anhalt, DE | — | |
| 1526711 | ISOMEDIX OPERATIONS INC | GROVEPORT, OH, US | NAI | |
| 1643817 | ISOMEDIX OPERATIONS INC | EL PASO, TX, US | NAI | |
| 1220477 | ISOMEDIX OPERATIONS INC. | Northborough, MA, US | NAI | |
| 1720929 | ISOMEDIX OPERATIONS INC. | Sandy, UT, US | NAI | |
| 1000136478 | ISOMEDIX OPERATIONS INC. | CHESTER, NY, US | VAI | |
| 2245304 | ISOMEDIX OPERATIONS INC. | WHIPPANY, NJ, US | NAI | |
| 1047843 | ISOMEDIX OPERATIONS INC. | SPARTANBURG, SC, US | NAI | |
| 3009888344 | Isomedix Operations Inc | El Paso, TX, US | NAI | |
| 3013820501 | Isomedix Operations Inc. | Chester, NY, US | NAI | |
| 3003076831 | Isomedix Operations Inc. | SAN DIEGO, CA, US | NAI | |
| 2246552 | Isomedix Operations Inc. | S Plainfield, NJ, US | NAI | |
| 3002681132 | Isomedix Operations Inc. | GRAND PRAIRIE, TX, US | NAI | |
| 3003058448 | Isomedix Operations, Inc | ONTARIO, CA, US | NAI | |
| 1450662 | Isomedix Operations, Inc. | Libertyville, IL, US | NAI | |
| 3000206435 | Isomedix Operations, Inc. | Temecula, CA, US | NAI | |
| 3003015552 | Isomedix Operations, Inc. | Libertyville, IL, US | NAI | |
| 2183744 | Isomedix Operations, Inc. | Minneapolis, MN, US | NAI | |
| 2183785 | Key Surgical, LLC | Eden Prairie, MN, US | VAI | |
| 3000255542 | MEDISAFE UK LTD. | Bishops Stortford Hertfordshire, GB | — | |
| 3018811167 | MEDIVATORS INC | Rogers, MN, US | — | |
| 2150060 | Medivators Inc | MINNEAPOLIS, MN, US | VAI |
Showing 1–25 of 72Next →