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STERIS CORPORATION · Model BF198 · UDI-DI 00724995226626

BWN

510(k) clearances

225

Adverse events (1 deaths)

Recalls

155

Facilities

Description

The Mushroom to Velcro Retrofit Kit is used with TLT Pads and on STERIS 4000 and 5000 Series Surgical Tables.

Recalls

Date	Firm	Reason
2026-07-24	QUANTUM OPS Inc	Due to a manufacturing issue (inadequate weld) for patient head positioning system.
2021-09-13	Innovative Orthopedic Technologies, LLC	Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.