Kerlix Gauze Rolls Recalled for Potential Sterility Breach
COVIDIEN LLC is recalling Kerlix Gauze Rolls due to a potential seal defect that could compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterility breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
COVIDIEN LLC is recalling Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880. The recall involves 2,730,821 units distributed nationwide in the United States. The affected lot numbers are 18E030462, 18E223262, and 18F122962.
The recall was initiated due to a potential for product sterility breach caused by a compromised or pinched seal defect. These products are used as both primary and secondary dressings for bandaging heads, limbs, and difficult-to-dress wounds.
Consumers and healthcare facilities should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the recalling firm, COVIDIEN LLC, in accordance with their instructions.
The recalled product
- Product
- 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.
- Manufacturer
- COVIDIEN LLC
- Affected units
- 2,730,821
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: 18E030462
- 18E223262
- 18F122962
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by COVIDIEN LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · COVIDIEN LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · sterility breach
See all →- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- HighIntracept Access Instruments sterile barrier breach risk
FDA (Devices) · 2026-07-15
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08