Z-2755-2016Class II

Intermediate carton label reads in part as: "Bard-ParkerStainless Steel Surgical Blades#12B***QTY 150...

Name: Z-2755-2016 Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150...
Creator: Aspen Surgical Puerto Rico Corp.
Published: 2016-06-27
License: https://open.fda.gov/license/

Aspen Surgical Puerto Rico Corp. / initiated 2016-06-27 / Terminated

FDA source

Aspen Surgical Puerto Rico Corp. began a recall of Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for... on 2016-06-27. FDA classified it as Class II and gives the reason as "After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2755-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-27
Posted: 2016-09-08
Terminated: 2017-05-15
Recalling firm: Aspen Surgical Puerto Rico Corp.
Product: Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
Product code: GES Blade, Scalpel
Reason for recall: After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.
FDA root cause: Mixed-up of materials/components
Action: An "Urgent: Medical Device Correction" letter was sent on June 27, 2016. The letter provided background on the issue, as well as actions to be taken by the user. Customers have the alternative to either keep the product or return it for replacement. A response form was included for customers to complete and return. Customers are to maintain awareness of the incorrect identification prior to use. Questions concerning the correction can be directed to [email protected].
Quantity in commerce: 6,000 pieces
Distribution: US distribution only.
Product codes and lots: LOT 0088464

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2755-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2755-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code GES

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)