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U.S. Department of Health and Human Services

Class 2 Device Recall Ethicon

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 Class 2 Device Recall Ethiconsee related information
Date Initiated by FirmMay 15, 2019
Create DateJune 26, 2019
Recall Status1 Terminated 3 on June 11, 2020
Recall NumberZ-1889-2019
Recall Event ID 82973
510(K)NumberK172580 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductEthicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Code Information All lot numbers
FEI Number 1527736
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information ContactSAME
513-337-7000
Manufacturer Reason
for Recall		Observed reported incidence rate for harm associated with intraoperative bleeding
FDA Determined
Cause 2		Under Investigation by firm
ActionEthicon issued Urgent Medical Device recall letter dated May 15, 2019 advising of product problem, health risk, and action to take: determine if you have product subject to this recall (removal) on hand and quarantine such product(s); 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall (removal) letter when communicating. 4. Complete the Business Reply Form (BRF) 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Customers are required to return unused impacted ENSEAL X1 Curved Jaw Tissue Sealer in their inventory immediately. Questions customer complaints contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.
Quantity in Commerce1059 boxes
DistributionNationwide Foreign: CANADA, AUSTRALIA, BELGIUM
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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