[pending] InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELG
Pending LLM rewrite. Source: FDA_DEVICE Z-1650-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.
The recalled product
- Product
- InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI(GTIN)/Lot: MMT-105NNBLNA/763000827182/D0020
- D0034
- D0036
- D0038
- D0045
- D0046
- D0050
- D0057
- MMT-105NNGYNA/763000827199/D0026
- D0037
- D0039
- D0041
- D0042
- D0043
- D0049
- MMT-105NNPKNA/763000827205/D0029
- D0030
- D0040
- D0051
- D0062
Distribution
Distributed in 41 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- FL
- GA
- HI
- IA
- IL
- IN
- KS
- LA
- MA
- MD
- MI
- MN
- MO
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- VA
- WA
- WI
- WV
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