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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74242

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 07, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Unomedical As

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Z-0355-2017
Recall number
Z-0355-2017
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Unomedical As
Quantity
1,295,515 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tubing detachment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tubing detachment

Code information

5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 5033754, 5033755, 5034062, 5034063, 5034064, 5034199, 5034200, 5035085, 5035086, 5035098, 5035099, 5035100, 5037024, 5037025, 5038106, 5038107, 5038108, 5038109, 5038110, 5040382, 5040939, 5040940, 5040941, 5040942, 5040943, 5040944, 5040945, 5040946, 5041053, 5041054, 5041055, 5041056, 5041057, 5043820, 5044874, 5044875, 5044876, 5044877, 5044878, 5044879, 5044880, 5044881, 5044882, 5047110, 5047111, 5047112, 5047113, 5047115, 5047116, 5047117, 5047118, 5047119, 5047121, 5051915, 5053663, 5053664, 5053665, 5053666, 5053667, 5053668, 5053669, 5053670, 5054453, 5054455, 5054456, 5054457, 5054458, 5054459, 5054460, 5054467, 5056817, 5056855, 5056856, 5056857, 5058622, 5058632, 5058636, 5058638, 5058639, 5058640, 5058641, 5058642, 5058735, 5060034, 5060036, 5060037, 5060038, 5060042, 5062768, 5062779, 5062781, 5062782, 5062783, 5062796, 5062814, 5062815, 5065701, 5066393, 5066981, 5066984, 5066992, 5067121, 5067122, 5067123, 5067124, 5067126, 5067127, 5067128, 5067129, 5067130, 5067131, 5067132, 5067133, 5067134, 5067137, 5070832, 5071891, 5071892, 5075507, 5075508, 5075510, 5075533, 5076039, 5077501, 5035530, 5035531, 5035532, 5054472, 5054473, 5054474, 5054479, 5054480, 5063759, 5063760, 5063761

Distribution pattern

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

device · product 2 of 6

Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Z-0356-2017
Recall number
Z-0356-2017
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Unomedical As
Quantity
664,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tubing detachment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tubing detachment

Code information

5031810, 5034061, 5034232, 5035097, 5036348, 5038182, 5038183, 5038184, 5038185, 5038186, 5038187, 5038188, 5040990, 5040991, 5040992, 5041073, 5041074, 5045147, 5045148, 5047241, 5047242, 5047243, 5047245, 5048097, 5053689, 5054465, 5054466, 5054550, 5054553, 5054554, 5057103, 5057104, 5057105, 5057106, 5058633, 5058637, 5058731, 5058732, 5058733, 5058734, 5062769, 5062770, 5062780, 5062811, 5062812, 5062813, 5066512, 5066999, 5067219, 5067220, 5067221, 5067222, 5067223, 5067224, 5067225, 5067226, 5067574, 5068464, 5068465, 5071889, 5073670, 5073671, 5075505, 5075509, 5076078, 5054475, 5054476, 5054477, 5054478, 5063762, 5063763

Distribution pattern

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

device · product 3 of 6

AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Z-0357-2017
Recall number
Z-0357-2017
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Unomedical As
Quantity
653,280 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tubing detachment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tubing detachment

Code information

5032433, 5033654, 5037164, 5040419, 5044362, 5046682, 5051308, 5053298, 5058508, 5061927, 5062202, 5065546, 5069297, 5072252, 5075118, 5044359, 5053289, 5061929, 5032436, 5033657, 5037159, 5040420, 5044355, 5046683, 5051309, 5053299, 5058501, 5061928, 5062205, 5065539, 5069295, 5072249, 5032442, 5033662, 5037162, 5040424, 5044361, 5051304, 5053292, 5058505, 5061931, 5061933, 5062208, 5032438, 5037160, 5044360, 5051310, 5053300, 5062211, 5069296, 5072253, 5032439, 5032440, 5033659, 5033660, 5037161, 5040422, 5044365, 5046684, 5051303, 5053297, 5058503, 5061939, 5062212, 5065550, 5065551, 5069298, 5072250, 5075121, 5032441, 5033661, 5037167, 5040423, 5044366, 5046681, 5051311, 5053293, 5058504, 5061930, 5065552, 5069301, 5072254, 5033658, 5044363, 5062206, 5062207, 5065540, 5065541, 5065542, 5069302, 5072251

Distribution pattern

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

device · product 4 of 6

Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Z-0358-2017
Recall number
Z-0358-2017
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Unomedical As
Quantity
22,114 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tubing detachment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tubing detachment

Code information

5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964

Distribution pattern

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

device · product 5 of 6

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

Z-0359-2017
Recall number
Z-0359-2017
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Unomedical As
Quantity
9,782,880 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tubing detachment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tubing detachment

Code information

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, 5058433, 5059933, 5061646, 5061670, 5061967, 5063527, 5063528, 5063628, 5066395, 5067505, 5067604, 5067605, 5070166, 5070833, 5070834, 5072351, 5030865, 5031737, 5031738, 5032665, 5032670, 5032671, 5032759, 5032760, 5033423, 5033424, 5034312, 5034313, 5034314, 5034315, 5034316, 5036334, 5038842, 5038843, 5039574, 5039988, 5039989, 5039990, 5039991, 5039992, 5039993, 5040164, 5040165, 5041846, 5041847, 5041848, 5041855, 5041856, 5042469, 5042470, 5042471, 5042549, 5042550, 5042592, 5042593, 5043394, 5043395, 5043396, 5043397, 5043398, 5043399, 5043400, 5042548, 5046464, 5046465, 5046560, 5046561, 5046562, 5046563, 5047497, 5047498, 5048108, 5048409, 5048410, 5049133, 5049134, 5049568, 5049569, 5049570, 5050058, 5051355, 5051356, 5051357, 5051358, 5052914, 5053725, 5053726, 5054287, 5054288, 5055346, 5055347, 5055389, 5055390, 5055391, 5059936, 5056165, 5056167, 5056174, 5057107, 5057108, 5057785, 5057786, 5058434, 5058435, 5058436, 5059300, 5059301, 5059302, 5059934, 5059935, 5059937, 5060839, 5060840, 5060841, 5061641, 5063529, 5063530, 5063531, 5063532, 5064184, 5064185, 5064852, 5064853, 5064854, 5064855, 5065534, 5065535, 5066616, 5066630, 5066631, 5066632, 5066633, 5067481, 5067606, 5067607, 5070167, 5070168, 5070835, 5070836, 5072352, 5072353, 5072354, 5073123, 5075677, 5076273, 5076274, 5046566, 5031739, 5031740, 5031741, 5031742, 5032656, 5032657, 5032761, 5032762, 5033425, 5033426, 5034237, 5034317, 5034318, 5034319, 5034320, 5034321, 5035645, 5035708, 5035709, 5035710, 5036335, 5037022, 6037924, 5037925, 5037926, 5037927, 5038849, 5038850, 5040036, 5040037, 5040038, 5040166, 5040167, 5040168, 5041849, 5041850, 5041851, 5041852, 5041853, 5041854, 5042472, 5042473, 5043407, 5042555, 5042562, 5043401, 5043402, 5043403, 5043404, 5043405, 5043406, 5043408, 5044098, 5044099, 5044100, 5044101, 5044102, 5046403, 5046404, 5046405, 5046564, 5046565, 5046566, 5046567, 5047503, 5047504, 5047505, 5047506, 5048411, 5048412, 5048413, 5049550, 5049552, 5049553, 5049554, 5049555, 5049561, 5049562, 5049838, 5049839, 5051359, 5051360, 5051361, 5051362, 5051363, 5051364, 5052915, 5052916, 5053727, 5053728, 5053729, 5053730, 5055336, 5055337, 5055338, 5055339, 5055392, 5055892, 5055893, 5055894, 5055899, 5055906, 5055907, 5055908, 5056652, 5056653, 5056654, 5056655, 5057109, 5057110, 5057787, 5057788, 5058437, 5058438, 5059303, 5059304, 5055900, 5059938, 5059939, 5059940, 5059941, 5060842, 5060843, 5060844, 5061642, 5061643, 5061644, 5061645, 5064186, 5064187, 5064188, 5064189, 5064190, 5065856, 5064857, 5065536, 5065537, 5065538, 5066396, 5066397, 5066398, 5066433, 5066501, 5066552, 5066645, 5066646, 5066647, 5067488, 5067489, 5067491, 5067492, 5067498, 5067594, 5067595, 5067596, 5067597, 5067598, 5067599, 5067600, 5070169, 5070170, 5070171, 5070837, 5072355, 5072356, 5072742, 5072743, 5072744, 5072745, 5076275, 5076276, 5076277, 5076278, 5076279, 5043409, 5032628, 5032763, 5034322, 5034323, 5038030, 5038069, 5038070, 5038071, 5040039, 5040169, 5042569, 5042571, 5042572, 5042716, 5042717, 5043409, 5043410, 5046568, 5048110, 5051365, 5052917, 5053731, 5054289, 5055811, 5055813, 5055989, 5057111, 5057789, 5058439, 5059305, 5059942, 5060845, 5060846, 5063533, 5063534, 5063535, 5063534, 5063629, 5067608, 5067609, 5067610, 5076280, 5076281, 5028970, 5030872, 5033532, 5034324, 5037929, 5042480, 5042718, 5046570, 5047123, 5048111, 5049988, 5050061, 5052918, 5055809, 5055988, 5056656, 5057790, 5058440, 5059306, 5059943, 5064858, 5066432, 5066652, 5067385, 5070838, 5073131, 5076282, 5032630, 5038025, 5038072, 5038073, 5042577, 5043411, 5046406, 5049989, 5051366, 5057112, 5058710, 5067386, 5073132, 5075678, 5076283,

Distribution pattern

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

device · product 6 of 6

SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Z-0360-2017
Recall number
Z-0360-2017
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Unomedical As
Quantity
4,748,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tubing detachment

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tubing detachment

Code information

5038783, 5040464, 5042582, 5042584, 5043414, 5043415, 5046638, 5046639, 5047168, 5049122, 5052903, 5052904, 5056680, 5057219, 5057241, 5057953, 5060205, 5061496, 5063694, 5064402, 5068516, 5068555, 5071403, 5072333, 5073682, 5075554, 5076349, 5043121, 5044843, 5057215, 5064141, 5068515, 5035649, 5035690, 5039578, 5039579, 5039580, 5039581, 5040158, 5040159, 5040465, 5040466, 5040467, 5040468, 5042578, 5042580, 5042581, 5043094, 5043095, 5043100, 5043106, 5043387, 5043417, 5043418, 5043419, 5046393, 5046395, 5046396, 5046640, 5046641, 5047170, 5047171, 5047510, 5047511, 5047580, 5047581, 5047582, 5049123, 5050034, 5050035, 5050036, 5051560, 5051561, 5051562, 5052905, 5052906, 5053786, 5053787, 5053788, 5054558, 5054559, 5055496, 5055497, 5056681, 5056682, 5057047, 5057221, 5057226, 5057231, 5057232, 5057242, 5057243, 5057251, 5057954, 5057955, 5060206, 5060207, 5060208, 5060946, 5060947, 5060948, 5060949, 5060988, 5060989, 5063695, 5063696, 5064142, 5064143, 5064144, 5064145, 5065089, 5065090, 5065106, 5066445, 5066513, 5066514, 5066524, 5067182, 5067183, 5067587, 5067589, 5067590, 5068518, 5068520, 5068522, 5070664, 5072716, 5072717, 5075402, 5075403, 5075555, 5075556, 5075557, 5076350, 5077461, 5077462, 5078949, 5053658, 5064299, 5032640, 5039582, 5039589, 5040469, 5041195, 5043329, 5043420, 5043421, 5046397, 5047172, 5047175, 5047583, 5049124, 5050037, 5051563, 5052907, 5053661, 5056683, 5057244, 5058702, 5058704, 5059523, 5059551, 5059552, 5060209, 5060950, 5061497, 5063697, 5064403, 5066515, 5067184, 5067592, 5068528, 5071405, 5072347, 5072718, 5075404, 5075558, 5077463, 5038779, 5032646, 5040470, 5040471, 5041196, 5043112, 5043114, 5043422, 5043423, 5044841, 5047177, 5047584, 5050038, 5051564, 5052908, 5055463, 5055465, 5056684, 5057245, 5060210, 5060951, 5060952, 5060990, 5067185, 5067593, 5068526, 5070666, 5071406, 5072719, 5075405, 5077464, 5078950, 5057216, 5032652, 5040472, 5040473, 5043117, 5043425, 5043426, 5043427, 5046644, 5046645, 5047179, 5049125, 5053789, 5055498, 5058706, 5058708, 5059553, 5060953, 5060991, 5066516, 5068531, 5070667, 5071407, 5072631, 5076348, 5076353, 5077465, 5039586, 5040474, 5072633, 5079671, 5038787, 5043124, 5043428, 5043429, 5053790, 5064146, 5064404, 5068530, 5068557, 5072634

Distribution pattern

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.