Z-1885-2018Class II

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length...

Name: Z-1885-2018 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length...
Creator: Ethicon Endo-Surgery Inc
Published: 2018-03-26
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2018-03-26 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery Inc began a recall of 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT on 2018-03-26. FDA classified it as Class II and gives the reason as "Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1885-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Posted: 2018-05-15
Terminated: 2020-04-08
Recalling firm: Ethicon Endo-Surgery Inc
Product: 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified customers and distributors by letter on March 26, 2018, and March 27, 2018, respectively. Customers were informed of the issue and potential risk of prolonged surgery or introduction of minute particles. Customers were instructed to: 1. Examine your inventory immediately to determine if you have any products subject to this recall on hand and quarantine such product(s). 2. Remove the products subject to this recall from your inventory and communicate the issue to all relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any of the devices subject to this recall have been forwarded to another facility, please contact that facility to arrange return. 3. Complete the Business Reply Form confirming receipt of this notice and fax or email it to Stericycle at 1-888-965-5794 or [email protected] within three (3) business days. Please return the BRF even if you do not have the product lot subject to this recall. 4. Customers are required to return all unused devices subject to this recall that are in their inventory immediately. 5. To return unused devices subject to this recall photocopy the completed BRF, place it in the box with the subject product(s), and affix the pre-paid authorized shipping label included with this recall notification letter. Distributors were instructed to: 1. Examine your inventory immediately to determine if you have the product lot subject to this recall on hand and quarantine such product(s). 2. Remove the product lot subject to this recall and communicate the issue to all relevant materials management personnel, or anyone else in your facility who needs to be informed. 3. Complete the Business Reply Form confirming receipt of this notice and fax or email it to Stericycle at 1-888-965-5794 or [email protected] within three (3) business days. Please return the BRF even if you do not have the product lot subject to this rec
Quantity in commerce: 118352
Distribution: Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
Product codes and lots: Lots P4T58Y P4T59E P4T627 P4T665 P4T66C P4T716 P4T71L P4T780 P4T83K P4T844 P4T87R P4T88E P4T88G P4T88H P4T927 P4T942 P4T946 P4T94D P4TA19 P4TA3V P4TA4N P4TA4R P4TA9K P4TA9R P4TC2E P4TC2T P4TC67 P4TC6Z P4TD1M R4000W R40045 R4004G R4007H R4013R R40172 R4017C R4021R R4021U R4023D R40267 R4026E R4031V R4036K R4036V R40397 R4041C R4041J R4044A R4044K R4048E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1885-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1885-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1886-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1887-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1888-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1889-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15

Product code GCJ

K032676Class IIEndopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarEthicon Endo-Surgery, Inc. / cleared 2003-10-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)