Use cautionMedical device recall · FDA · Published August 4, 2020
Integra Padgett Dermatome Set Recall: Handpiece Cable Melts After Sterilization
Integra recalls specific models of dermatome sets used in plastic surgery due to handpiece cable melting after sterilization. Affected units must be checked for melted cables and disposed of safely.
“Integra Padgett Dermatome Set Recall: Handpiece Cable Melts After Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64528-integra-padgett-dermatome-set-recall-handpiece-cable-melts-after-sterilization. Based on FDA recall #Z-2954-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2954-2020%22&limit=1).
The FDA announced on 2020-08-04 that Integra LifeSciences Corp. is recalling Integra Padgett Dermatome Sets because the handpiece cable may melt after sterilization. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Integra
Product: Integra Padgett Dermatome Set
Catalog Number: 3539700
Model #: S
Lot/Serial #: S-1949, S-1919, S-1930 to S-1932, S-1937 to S-1939, S-1944 to S-1946, S-1927, S-1928
The hazard
Integra LifeSciences identified through complaints that the handpiece cable melts following sterilization. The record reports no specific incidents or injuries.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since 2017-08-18. Recent brand recalls include the Integra AURORA Surgiscope System Recall (2025-02-06), MediHoney Wound Dressing Gel Recall (2025-01-10), and Integra LifeSciences CODMAN CERTAS Plus Valve Recall (2024-12-16). Other recent recalls of similar products include the Integra CVS Wound Dressing Recall (2026-01-16), Medline Surgical Drapes Recall (2026-01-07), and MediHoney Gel Dressing Recall (2026-01-16).
How to tell if you have this one
Check for catalog numbers 3539700 with model S and lot/serial numbers S-1949 to S-1946 (including S-1927 and S-1928). These sets are sold only for professional medical use in hospitals.
Brand
Integra
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE, ES).
Recall number
Product, codes & lots
Quantity
Z-2953-2020
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.; Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195
74 units
Z-2954-2020
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.; Catalog Number: 3539700 Catalog Description: Slimline Dermatome Set Model #: S Lot/Serial #: S-1949, S-1919, S-1930 to S-1932, S-1937 to S-1939, S-1944 to S-1946 ***Updated 5/3/21*** S-1927, S-1928
13 units
Z-2955-2020
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.; Catalog Number: 3539900 Catalog Description: Electric Dermatome Set Model #: S6 Lot/Serial #: S-594-6 NOT SOLD IN USA
2 units
Based on the official FDA remedy
What to do — step by step
Check for Melted Cable
Inspect the handpiece cable for melting after sterilization. If melted, stop using the device immediately.
Contact Manufacturer
Reach out to Integra LifeSciences for guidance on safe disposal or replacement of the affected units.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE, ES).” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Indiana, Minnesota, Texas, Utah, West Virginia.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2954-2020 (August 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2954-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.