Recall of Medline TAVR PACK Medical Kits
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP is recalling 108 units of their TAVR PACK medical convenience kits due to a potential risk of syringe disconnection during use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 23, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medline Industries, LP has initiated a voluntary recall because of a potential risk where the syringe rotating adaptor may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold.
Which Products Are Affected
The affected products are Medline medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes, specifically labeled as TAVR PACK with Medline SKU # DYNJ84472. This recall involves 108 units with Lot Numbers: 23LBN016, 23KBL255, 23HBL885, and 23FBV799. The UDI/DI for each unit is 10195327369286, and for the case is 40195327369287. The products were distributed worldwide, including the United States nationwide and Puerto Rico, as well as to countries such as Canada, Netherlands, Australia, Korea, Republic of, Sri Lanka, Pakistan, Japan, United Arab Emirates, Singapore, and Slovakia.
What You Should Do
Consumers who have the affected products should follow the firm's notification methods, which include email, fax, letter, press release, telephone, or visit, to get further instructions from Medline Industries, LP regarding this recall.
Why This Matters
This recall is classified as Class I by the FDA, indicating a reasonable probability of serious adverse health consequences, underscoring the need for proper medical device functionality to ensure patient safety.
Source
Attribution: FDA. For more information, visit the FDA website at https://www.fda.gov/.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,492 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 23, 2026.
Frequently Asked Questions
Common questions about this FDA recall.