Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
Why it was recalled
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
DYNJ43427C , Lot Number 21HBA933 ; DYNJ43427C , Lot Number 22ABL557 ; DYNJ43427C , Lot Number 22BBL591 ; DYNJ43427C , Lot Number 19ABE939 ; DYNJ43427C , Lot Number 19ABM274 ; DYNJ43427C , Lot Number 19ABT846 ; DYNJ43427C , Lot Number 22DBL373 ; DYNJ43427C , Lot Number 22FBV273 ; DYNJ43427C , Lot Number 22GBE783 ; DYNJ43427C , Lot Number 22HBY245 ; DYNJ43427C , Lot Number 22IBS212 ; DYNJ43427C , Lot Number 19IBD112 ; DYNJ43427C , Lot Number 22KBT930 ; DYNJ43427C , Lot Number 22KBV623 ; DYNJ43427C , Lot Number 19JBZ344 ; DYNJ43427C , Lot Number 23ABM258 ; DYNJ43427C , Lot Number 23CBQ295 ; DYNJ43427C , Lot Number 23DBQ887 ; DYNJ43427C , Lot Number 23EBQ116 ; DYNJ43427C , Lot Number 20BBH601 ; DYNJ43427C , Lot Number 23GBI661 ; DYNJ43427C , Lot Number 20DBE542 ; DYNJ43427C , Lot Number 23HBQ003 ; DYNJ43427C , Lot Number 20EBM157 ; DYNJ43427C , Lot Number 23JBX153 ; DYNJ43427C , Lot Number 20GBU737 ; DYNJ43427C , Lot Number 20HBR283 ; DYNJ43427C , Lot Number 23LBR867 ; DYNJ43427C , Lot Number 20IBB669 ; DYNJ43427C , Lot Number 20IBK144
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution.
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-3000-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Northfield, IL
- Recall initiated
- 2024-04-08
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-3000-2024 · Source: openFDA enforcement.