FDA · Medical device recall

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE… and 2 more products

July 3, 2019 Class II

Date: July 3, 2019
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Ethicon Endo-Surgery Inc
Reason: Observed reported incidence rate for harm associated with intraoperative bleeding
Distribution pattern: Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM

3 products in this recall

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C

Product: Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Quantity: 228 boxes
Codes and lots: All lot numbers
Recall started: May 15, 2019
Device type: Electrosurgical, Cutting & Coagulation & Accessories
Root cause (FDA): Under Investigation by firm
What the company told customers: Ethicon 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.
Recall number: Z-1888-2019

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C

Product: Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Quantity: 1059 boxes
Codes and lots: All lot numbers
Recall started: May 15, 2019
Device type: Electrosurgical, Cutting & Coagulation & Accessories
Root cause (FDA): Under Investigation by firm
What the company told customers: Ethicon 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.
Recall number: Z-1889-2019

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C

Product: Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Quantity: 308 boxes
Codes and lots: All lot numbers
Recall started: May 15, 2019
Device type: Electrosurgical, Cutting & Coagulation & Accessories
Root cause (FDA): Under Investigation by firm
What the company told customers: Ethicon 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.
Recall number: Z-1890-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1888-2019, Z-1889-2019, Z-1890-2019. The agency record governs; check it and the company before acting.

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