Agency classClass IIOur severity:High FDA (Devices)·Z-2309-2026·Announced 2026-06-10

Sharpoint microsurgical knives labeled 2.2mm actually measure 3.0mm

Sharpoint 2.2 mm angled double-bevel microsurgical knives are being recalled because 3.0 mm knives were labeled and packaged as 2.2 mm. 1,818 units affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where a surgical blade is a larger size than its label states, a risk of harm with no injuries reported in the source.

Plain-English summary

The Sharpoint 2.2 mm angled, double-bevel microsurgical knife, model/catalog number 72-2231, UDI-DI 00848782027514, is being recalled. The action covers 1,818 units in lot FA22CHQ.

The stated reason is that 3.0 mm surgical knives were labeled and packaged as 2.2 mm surgical knives. The FDA classified the action as Class II.

Distribution was worldwide, including within the United States in Texas, Utah and Michigan. The knives are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the catalog number, UDI-DI and lot number above, quarantine it, and follow the instructions issued by the manufacturer.

The recalled product

Product: Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
Manufacturer: SSC- Surgical Specialties Corporation
Category: Medical Device — Surgical knife
Hazard: mislabeled-size
wrong-dimension
surgical-instrument
class-ii
Affected units: 1,818

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI-DI 00848782027514
Lot Number FA22CHQ

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · SSC- Surgical Specialties Corporation

See all →

Moderate
Surgical Specialties Recalls Sharpoint Polypropylene Suture Due to Contamination
FDA (Devices) · 2016-06-29

Same hazard · mislabeled size