FDA Reports Ongoing Class II Recall of Convenience Kits from Medline and AVID Medical
The U.S. Food and Drug Administration has reported an ongoing Class II recall of convenience kits distributed by Medline and AVID Medical due to sterility concerns.
5 reports on this incident · first at Sep 2, 2026, 7:11 p.m. ET
Earlier reports
Sep 2, 2026, 7:22 p.m. ET
FDA Expands Medline Convenience Kit Recall Over Sterility Concern
The FDA has expanded a recall of Medline convenience kits containing BD ChloraPrep applicators, according to a notice published September 2, 2026. The kits, which include surgical instruments, dressings, and pharmaceutical components for various procedures, may have compromised sterile barriers due to wrinkles in the paper lidding or an open or incomplete seal on the applicator packaging.
Medline is instructing users to remove affected BD ChloraPrep applicators and apply over-labels to all affected kits on hand stating that the components must be removed and discarded prior to use. As of August 3, Medline has reported no serious injuries or deaths associated with this issue, the FDA said.
The recall is classified as Class II, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences. The FDA notice does not specify which lot codes are affected in this expansion.
Sep 2, 2026, 7:21 p.m. ET
FDA Reclassifies Medline Convenience Kit Recall as Class II
The U.S. Food and Drug Administration has reclassified the Medline convenience kit correction as a Class II recall, according to an FDA notice dated September 2, 2026. The agency did not specify the previous classification in the notice.
The correction applies to convenience kits containing BD ChloraPrep applicators. The kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components intended for use during surgical procedures. The reason for the correction is a potential breach of sterility in the packaging due to wrinkles in the paper lidding that may extend to the seal area, or an open or incomplete seal on the applicator packaging.
If the sterile barrier is compromised, patients and users may be exposed to microbial contamination, with potential health consequences ranging from no injury to localized infection or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. As of August 3, Medline has reported no serious injuries or deaths associated with this issue.
The FDA instructs users to remove affected BD ChloraPrep applicators and apply over-labels to all affected kits on hand stating that the affected components must be removed and discarded prior to use.
Sep 2, 2026, 7:15 p.m. ET
FDA Reports No Serious Injuries or Deaths in Medline Convenience Kit Recall
As of August 3, Medline has reported no serious injuries or deaths associated with a potential sterility issue in certain convenience kits, the U.S. Food and Drug Administration (FDA) announced on September 2, 2026.
The FDA classified the action as a Class II recall. The affected convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components intended for use during surgical procedures. The reason for the correction is a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area, or the affected product may exhibit an open or incomplete seal on the packaging of the applicator.
If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization.
Medline has instructed users to remove affected BD ChloraPrep applicators and apply over-labels to all affected kits on hand stating that the affected components must be removed and discarded prior to use.
Sep 2, 2026, 7:11 p.m. ETFirst report
Medline Recalls Convenience Kits Over Sterility Concern
Medline has issued a correction for convenience kits containing BD ChloraPrep applicators, the U.S. Food and Drug Administration (FDA) announced on September 2, 2026. The recall is classified as Class II, according to the FDA.
The reason for the correction is a potential breach of sterility in the packaging, due to wrinkles in the paper lidding that may extend to the seal area, or the affected product may exhibit an open or incomplete seal on the packaging of the applicator, the FDA reported. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination, with potential health consequences ranging from no injury to localized infection or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization.
As of August 3, Medline has reported no serious injuries or deaths associated with this issue, according to the FDA. The convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components intended for use during various surgical procedures.
The FDA instructs users to remove affected BD ChloraPrep applicators and apply over-labels to all affected kits on hand stating that the affected components must be removed and discarded prior to use.
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Revision history
- Version 27 Sept 2026, 18:21current
Corrected status from closed to ongoing; updated remedy and hazard descriptions to reflect both FDA notices.
- Version 12 Sept 2026, 23:22current
First published.
- Version 12 Sept 2026, 23:11current
First published.
- Version 12 Sept 2026, 23:15current
First published.
- Version 12 Sept 2026, 23:21current
First published.
- Version 17 Sept 2026, 18:16
First published.
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