Pacemaker Implant Pack (Medline) – Subpotent Iodine Prep (2017)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
Brand
Medline Industries Inc
Lot Codes / Batch Numbers
Pack Number: DYNJ32856C, Lots 17SB6210, 17FB5359, 17SB6208
Products Sold
Pack Number: DYNJ32856C; Lots 17SB6210; 17FB5359; 17SB6208
Medline Industries Inc is recalling Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, due to Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026