Covidien Kerlix Bandage Roll Recall: Sterility Risk from Seal Defect
Covidien recalls Kerlix bandage rolls with potential sterility breach due to seal defects. Affected lots: 18E071762, 18E072262, 18E072362, 18E132262, 18E132362. Stop using if seal appears pinched.
Lower-risk recall
Potential for product sterility breach due to a compromised or pinched seal defect
Contact the company
What happened, in plain English
Covidien is recalling Kerlix bandage rolls that may have a seal defect causing sterility breaches. This could lead to infection if the bandage is used on wounds. Affected lots are listed in the recall notice. Read more at govinfonow.com/recall/70220-covidien-kerlix-bandage-roll-recall-sterility-risk-from-seal-defect.
Source Summary by GovInfoNow · govinfonow.com/recall/70220-covidien-kerlix-bandage-roll-recall-sterility-risk-from-seal-defect · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0016-2019
Cite this page
“Covidien Kerlix Bandage Roll Recall: Sterility Risk from Seal Defect.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70220-covidien-kerlix-bandage-roll-recall-sterility-risk-from-seal-defect. Based on FDA recall #Z-0016-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0016-2019%22&limit=1).
Why it’s dangerous
The bandage roll's seal may be pinched or compromised, allowing bacteria to enter the wound. This could cause infection if the bandage is used on open wounds or cuts.
Who’s affected
People who own or use Kerlix bandage rolls with the listed lot numbers. Those applying bandages to wounds are most at risk if the seal is compromised.
How to tell if you have this one
Check the lot number on the bandage roll packaging. Affected lots are 18E071762, 18E072262, 18E072362, 18E132262, and 18E132362.
- Brand
Covidien- Category
Medical device
All 6 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
US Nationwide Distribution
| Recall number | Product, codes & lots |
|---|---|
| Z-0013-2019 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.; Lot Numbers: 18D180962,18D181062,18E029462,18E029562,18E070762, 18E131262,18E131362,18E131462,18E166662,18E167362, 18E223462,18E223362,18F054362,18E222662,18F034762, 18F034662,18F035562,18F072862,18F072662,18F072962, 18F123062,18F122562,18F122662 |
| Z-0014-2019 | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.; Lot Numbers: 18D181262,18D181162,18E029662,18E029762,18E029862, 18E029962,18E030062,18E030162,18E030262,18E030362, 18E070962,18E071062,18E071162,18E071262,18E071362, 18E071462,18E071562,18E071662,18E131562,18E131962, 18E132062,18E132162,18E131662,18E131762,18E131862, 18E166762,18E167462,18E166862,18E166962,18E167562, 18E167162,18E167062,18E167762,18E167662,18E167262, 18E222762,18E223162,18E223062,18E222962,18E222862, 18E223662,18E223562,18E224062,18E223962,18E223862, 18E223762,18F035862,18F034962,18F034862,18F035262, 18F035162,18F035062,18F035362,18F035962,18F035762, 18F035462,18F089262,18F036262,18F036162,18F036062, 18F073062,18F072762,18F123262,18F123162,18F158462, 18F158362,18G004562 |
| Z-0015-2019 | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.; Lot Numbers: 18E030462,18E223262,18F122962 |
| Z-0016-2019 | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.; Lot Numbers: 18E071762,18E072262,18E072362,18E132262,18E132362 |
| Z-0017-2019 | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.; Lot Numbers: 18D180662,18E070362,18E222362,18F072362 |
| Z-0018-2019 | Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.; Lot Numbers: 18D180762,18D180862,18E029062,18E029162,18E029262, 18E029362,18E070662,18E070462,18E070562,18E130962, 18E131062,18E166462,18E166562,18E131162,18E222562, 18E222462,18F034562,18F034462,18F034362,18F072562, 18F072462,18F122462,18F122362 |
What to do — step by step
Check Bandage Seal
Look for pinched or compromised seals on the bandage roll packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0016-2019 (August 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0016-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.