- Recalling firm
- Cook Incorporated
- Reason for recall
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Affected products (lot / model / serial)
- Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260424(10)15569919, Lot Number 15569919; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260403(10)15520378, Lot Number 15520378; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15487727, Lot Number 15487727; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15484947, Lot Number 15484947; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)16617145, Lot Number 16617145; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617419, Lot Number NS16617419; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617420, Lot Number NS16617420; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620091, Lot Number NS16620091; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620092, Lot Number NS16620092; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620093, Lot Number NS16620093; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620094, Lot Number NS16620094; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620414, Lot Number NS16620414; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620415, Lot Number NS16620415; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620416, Lot Number NS16620416; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622160, Lot Number NS16622160; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622161, Lot Number NS16622161; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622162, Lot Number NS16622162; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622163, Lot Number NS16622163; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622164, Lot Number NS16622164; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622165, Lot Number NS16622165; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622166, Lot Number NS16622166; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622167, Lot Number NS16622167; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622168, Lot Number NS16622168; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280602(10)NS16625835, Lot Number NS16625835; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260619(10)NS15668028, Lot Number NS15668028; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260227(10)NS15473245, Lot Number NS15473245; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282739, Lot Number NS15282739; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282763, Lot Number NS15282763; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15583873, Lot Number NS15583873; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)280714(10)NS16692824, Lot Number NS16692824; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15557442, Lot Number 15557442; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15520367, Lot Number 15520367; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260220(10)15518160, Lot Number 15518160; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260327(10)15594051, Lot Number 15594051; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280426(10)165
- Units affected
- 5080 units
- Distribution pattern
- Worldwide distribution.
- Firm location
- Bloomington, IN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1788-2026
- Recall initiated
- March 5, 2026
- FDA classification date
- April 6, 2026
- FDA report date
- April 15, 2026
- FDA event ID
- 98495
- Last updated on HTM Vibe
- July 24, 2026