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Ambler Surgical

AMBLER SURGICAL CORP. · Model Henly retractor · UDI-DI 00190660136628

FFO Prescription

510(k) clearances

Adverse events

Recalls

152

Facilities

Description

Henly retractor, 6 1/2'', interchangeable blades, complete set includes 3 pairs of side blades 1'' x 7/8'' wide, 2'' x 7/8'' wide and 3'' x 7/8'' wide, with 4 blunt prongs, also 4 center blades 3/4'' x 5/8'' wide, 1'' x 5/8'' wide, 1 1/4'' x 5/8'' wide and 3'' x 5/8'' wide, ring handle with ratchet catch (71-890, 71-891, 71-892, 71-850, 71-851, 71-852, 71-853 and 71-855)

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2015-11-25	Abeon Medical Corporation	The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
2015-11-25	Abeon Medical Corporation	The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.

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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.