Medline Control Syringes Recall Over Rescinded Regulatory Clearances
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Medline Industries is recalling over 198,000 units of certain control syringes due to rescinded 510(k) regulatory clearances, affecting products distributed nationwide in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline Industries, LP is recalling certain control syringes because the 510(k) regulatory clearances for these products have been rescinded.
Which Products Are Affected
The affected products include:
- SYR CONTROL 8ML ROTATING, Model Number: DNSC89369, with UDI-DI: 10889942596225 (each) and 40889942596226 (case), Lot Number: 25BDB731.
- SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C, with UDI-DI: 10884389676462 (each) and 40884389676463 (case), and multiple lot numbers including 21BBM369, 21DBO183, 21DBY321, 21FBC554, 21FBJ020, 21FBU555, 21KBN994, 21KBV737, 22ABI338, 22DBT508, 22EBK614, 22IBH075, 22IBH622, 22IBU135, 22JBN943, 22LBO542, 22OBA220, 22OBG844, 23DBO855, 23FBM361, 23HBF967, 23HBM037, 23HBM038, 23HBZ420, 23IBD522, 23KBQ419, 24BBB469, 24EBT832, 24EBU578, 24EBV379, 24GBC953, 24GBK311, 24GBP361, 24GBQ243, 24GBV309, 24HBQ322, 24IBV756, 24KBF922, 24LBL381, 25ABI838, 25ABN037, 25ABO304, 25ABP830, 25BBA706, 25BBO573, 25CBQ928, 25EBC625, 25EBG123, 25EBJ932, 25EBN364, 25EBO179, 25EBQ230, 25EBT991, 25GBK401, 21ABS242, 22CBV056, 23DBH886, 24EBT833, 24HBV692, 25CBR555, and 25JDB828. A total of 198,210 units are affected, with distribution across the United States. The official recall number is Z-1843-2026.
What You Should Do
Consumers and users should stop using the affected products and contact Medline Industries, LP for instructions on returns or refunds, as initially notified via letter.
Why This Matters
This recall involves a significant number of medical devices distributed nationwide, potentially affecting patient safety due to the rescinded regulatory clearances.
Source
FDA Recall Notice: https://www.fda.gov (Attribution: FDA, Recall Number Z-1843-2026)
Original source: FDA Official Notice ↗
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