RecallRadar

FDA Device recall Z-1940-2015

Accurus 2500 Standalone Vitreous Probe REF 8065741018

On 2015-07-08 the FDA classified a Class II recall of Accurus 2500 Standalone Vitreous Probe REF 8065741018 by Alcon Research, citing insufficient seal on the outside packaging, potentially affecting the sterility of the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1940-2015
ClassificationClass II
Statusterminated
Initiated2015-06-02
Published2015-07-08
Last updated2026-09-13 11:53 UTC
CompanyAlcon Research
DistributionUS

Product

Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

Reason

Insufficient seal on the outside packaging, potentially affecting the sterility of the product.

Identifiers

code_info
Accurus 23 GA Standalone Vitreous Probe: Lot Number: 14010428X, Expiration Date: 1/14/2017; Lot Number: 14012987X, Expi…Accurus 23 GA Standalone Vitreous Probe: Lot Number: 14010428X, Expiration Date: 1/14/2017; Lot Number: 14012987X, Expiration Date: 2/17/2017; Lot Number: 14014736X, Expiration Date: 3/11/2017; Lot Number: 14016577X, Expiration Date: 3/26/2017; Lot Number: 14017912X, Expiration Date: 4/27/2017; Lot Number: 14020280X, Expiration Date: 5/21/2017; Lot Number: 14022920X, Expiration Date: 6/19/2017; Lot Number: 14024168X, Expiration Date: 6/22/2017; Lot Number: 14026031X, Expiration Date: 7/27/2017; Lot Number: 14028553X, Expiration Date: 8/12/2017; Lot Number: 14029477X, Expiration Date: 8/26/2017; Lot Number: 14033830X, Expiration Date: 10/14/2017; Lot Number: 14036315X, Expiration Date: 11/17/2017; Accurus 25+ 2500 CPM Stand-Alone Vitreous Probe: Lot Number: 14010429X, Expiration Date: 1/14/2014; Lot Number: 14012985X, Expiration Date: 2/17/2017; Lot Number: 14014737X Expiration Date: 3/11/2017; Lot Number: 14016477X Expiration Date: 3/26/2017; Lot Number: 14018320X Expiration Date: 4

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1940-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.