Medline ACDF and ACL procedure kits contain recalled Mastisol adhesive
Medline convenience kits for ACD, ACDF, ACL and ALIF procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where the described consequence is that a component becomes unusable rather than any patient hazard, which fits the Moderate band.
Plain-English summary
Medline convenience kits are being recalled, covering the ACD kit (DYNJ904999J), ACDF kits (DYNJ907336B, DYNJ910821A), the ACDF Pack (DYNJ81098C), ACL kits (DYNJ911996, DYNJ905281B), the ACL Accessory Pack (DYNJ86584B), the ACL Pack (DYNJ67271A) and the ALIF kit (DYNJ904848L), among the SKUs listed in the recall notice. The action covers 49,654 kits in total across the connected Medline Mastisol recalls.
The stated reason is that the kits contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive. According to the notice, the butyrate tubing may crack during actuation and render the product unusable for application. The FDA classified the action as Class II. The source does not describe any patient hazard beyond the product being unusable.
Distribution was nationwide in the United States, with distribution outside the United States pending.
Facilities should identify affected stock using the kit numbers, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by Medline.
The recalled product
- Product
- Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYN
- Manufacturer
- Medline Industries, LP
- Affected units
- 49,654
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Medline Industries, LP 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.
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