FDA Device recall Z-0359-2017

Silhouette Paradigm 13mm, 18"

FDA Device
Class II
terminated
Published 2016-11-09

On 2016-11-09 the FDA classified a Class II recall of Silhouette Paradigm 13mm, 18" by Unomedical As, citing tubing detachment.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0359-2017
Classification	Class II
Status	terminated
Initiated	2014-11-07
Published	2016-11-09
Last updated	2026-09-13 11:54 UTC
Company	Unomedical As
Distribution	CA, IN, PA

Product

Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Reason

Tubing detachment

Identifiers

code_info	5031734, 5034234, 5034311, 5035640, 5036333, 5037019, 5037922, 5037923, 5039570, 5040033, 5040162, 5040476, 5041194, 50… 5031734, 5034234, 5034311, 5035640, 5036333, 5037019, 5037922, 5037923, 5039570, 5040033, 5040162, 5040476, 5041194, 5043391, 5043392, 5046554, 5047941, 5048106, 5048106, 5049985, 5051351, 5052913, 5053724, 5054982, 5056181, 5056651, 5057784, 5059432, 5059299, 5059931, 5064182, 5064183, 5064848, 5064849, 5066434, 5066634, 5967602, 5067603, 5076272, 5032622, 5032758, 5034233, 5034310, 5035639, 5037920, 5037921, 5037930, 5039572, 5040161, 5043390, 5046552, 5048407, 5050059, 5051349, 5051349, 5066394, 5067601, 5075676, 5032623, 5038026, 5038063, 5038064, 5038065, 5040032, 5040475, 5049408, 5042573, 5044092, 5048408, 5049833, 5051350, 5052912, 5053723, 5057783, 5058431, 5059298, 5061640, 5070165, 5072741, 5031735, 5031736, 5032662, 5032663, 5034236, 5035643. 5035644, 5037021, 5038839, 5039986, 5039987, 5040035, 5040163, 5042478, 5042575, 5042576, 5042714, 5042715, 5043393, 5046462, 5046463, 5046558, 5047107, 5047491, 5047942, 5047943, 5050056, 5050057, 5051352, 5051353, 5051354, 5057791,

code_info

5031734, 5034234, 5034311, 5035640, 5036333, 5037019, 5037922, 5037923, 5039570, 5040033, 5040162, 5040476, 5041194, 50…

5031734, 5034234, 5034311, 5035640, 5036333, 5037019, 5037922, 5037923, 5039570, 5040033, 5040162, 5040476, 5041194, 5043391, 5043392, 5046554, 5047941, 5048106, 5048106, 5049985, 5051351, 5052913, 5053724, 5054982, 5056181, 5056651, 5057784, 5059432, 5059299, 5059931, 5064182, 5064183, 5064848, 5064849, 5066434, 5066634, 5967602, 5067603, 5076272, 5032622, 5032758, 5034233, 5034310, 5035639, 5037920, 5037921, 5037930, 5039572, 5040161, 5043390, 5046552, 5048407, 5050059, 5051349, 5051349, 5066394, 5067601, 5075676, 5032623, 5038026, 5038063, 5038064, 5038065, 5040032, 5040475, 5049408, 5042573, 5044092, 5048408, 5049833, 5051350, 5052912, 5053723, 5057783, 5058431, 5059298, 5061640, 5070165, 5072741, 5031735, 5031736, 5032662, 5032663, 5034236, 5035643. 5035644, 5037021, 5038839, 5039986, 5039987, 5040035, 5040163, 5042478, 5042575, 5042576, 5042714, 5042715, 5043393, 5046462, 5046463, 5046558, 5047107, 5047491, 5047942, 5047943, 5050056, 5050057, 5051352, 5051353, 5051354, 5057791,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0359-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.