CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Intermediate carton label reads in part as recalled
Aspen Surgical Puerto Rico is recalling Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical. The recall was initiated on 27 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2755-2016
- FDA event ID
- 74584
- Recalling firm
- Aspen Surgical Puerto Rico, Las Piedras, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2016
- FDA classified
- 8 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 27 Jun 2016 | Recall initiated by company | |
| 8 Sep 2016 | Classified by FDA | +73 days |
| 14 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
US distribution only.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
LOT 0088464
Where was it sold?
US distribution only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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