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Forsure

FORSURE MEDICAL PRODUCTS LLC · Model 11100050 · UDI-DI 00815123011372

BTO Prescription

510(k) clearances

6,618

Adverse events (163 deaths)

Recalls

Facilities

Description

A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device.

Recalls

Date	Firm	Reason
2026-04-23	Covidien LLC	Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
2024-06-07	Smiths Medical ASD Inc.	There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a
2024-06-07	Smiths Medical ASD Inc.	There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a
2024-06-07	Smiths Medical ASD Inc.	There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a
2024-05-29	Smiths Medical ASD Inc.	Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec
2024-05-29	Smiths Medical ASD Inc.	Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec
2024-05-29	Smiths Medical ASD Inc.	Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec
2024-05-29	Smiths Medical ASD Inc.	Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec
2024-05-29	Smiths Medical ASD Inc.	Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec
2024-05-29	Smiths Medical ASD Inc.	Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec

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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.