CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report

Pipeline LS Access System, 2nd Dilator recalled by DePuy Spine

DePuy Spine is recalling Pipeline LS Access System, 2nd Dilator, Insulated The Pipeline LS Dilators and Holding, distributed nationwide in the US. The recall was initiated on 31 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes287105010

Quantity recalled105 units

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-0094-2014
FDA event ID: 65897
Recalling firm: DePuy Spine, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2013
FDA classified: 28 Oct 2013
Reported: 6 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

31 Jul 2013	Recall initiated by company
28 Oct 2013	Classified by FDA	+89 days
6 Nov 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Product as listed by the FDA

PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

Where it was distributed

Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.

Nationwide Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota

Questions about this recall

Is Pipeline LS Access System, 2nd Dilator, Insulated The Pipeline LS Dilators and Holding recalled?

Yes. DePuy Spine recalled Pipeline LS Access System, 2nd Dilator, Insulated The Pipeline LS Dilators and Holding on 31 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-0094-2014.

Why was it recalled?

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Which lots are affected?

287105010

Where was it sold?

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 21 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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