Use caution Medical device recall · FDA · Published February 25, 2021

Tenacore Alaris Infusion Pump 8100 Bezel Recall: Cracking Risk

Tenacore recalls Alaris Infusion Pump 8100 bezel parts (TIPA-8100-4410) sold 2020-2021. Cracking may cause infusion issues. Check your pump for 5-6 SO numbers on bezel.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1332-2021Medical device Tenacore ›

Use caution until it’s fixed

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

Take action

Contact the company

Recalling firmTenacore LLC1525 E Edinger Ave · Santa Ana, CA 92705-4907

✎ GovInfoNow plain-language explainer

Tenacore is recalling a specific plastic bezel part for their Alaris Infusion Pump 8100. This part, sold between July 2020 and January 2021, can crack over time and cause infusion problems like over-infusion or interruptions. Read more at govinfonow.com/recall/63228-tenacore-alaris-infusion-pump-8100-bezel-recall-cracking-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63228-tenacore-alaris-infusion-pump-8100-bezel-recall-cracking-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1332-2021

Cite this page

“Tenacore Alaris Infusion Pump 8100 Bezel Recall: Cracking Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63228-tenacore-alaris-infusion-pump-8100-bezel-recall-cracking-risk. Based on FDA recall #Z-1332-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1332-2021%22&limit=1).

The FDA announced on Feb. 25, 2021, that Tenacore LLC is recalling the Alaris Infusion Pump 8100 Bezel (part TIPA-8100-4410) because the plastic repair parts may crack or separate. This defect can cause free flow, over infusion, under infusion, or interruption of infusion.

How to tell if you have it

Brand: Tenacore
Product: Alaris Infusion Pump 8100 Bezel (plastic piece only)
Part number: TIPA-8100-4410
SO Numbers: 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, 267392
Distribution: US states including WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA between July 10, 2020, and January 22, 2021

The hazard

According to the FDA, the bezel repair parts used to service infusion pump modules may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

Context

GovInfoNow's records show other recent recalls of similar products include Fresenius Kabi LVP-0004 Infusion Pump Recall (2026-02-04) and BD Alaris Pump Infusion Sets Recall (2026-08-19). Other recent recalls of similar products include Stryker XCEL Bladeless Trocar W/Stability Sleeve 12x100mm Recall (2026-08-19).

How to tell if you have this one

Check for the part number TIPA-8100-4410 on the bezel. The bezel has a time stamp showing 5 or 6 SO numbers listed in the recall notice.

Brand
Tenacore
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA

Recall number	Product, codes & lots	Quantity
Z-1331-2021	Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part; Serviced/Repaired between July 10, 2020 and February 18, 2021 with Serial Numbers: 14789900, 14426738, 14426703, 9856983, 4038121, 9586652, 12421654, 4035910, 4037310, 4040396, 12653566, 13979989, 13410610, 12389912, 12358178, 13040916, 12390023, 12534649, 4038582, 12533626, 12389988, 13004789, 13040564, 9856969, 4040071, 12437067, 404843, 13410468, 12934959, 12534587, 4047842, 12436857, 12533639, 405074, 4037334, 12935440, 12533768, 4040123, 14020832, 14021684, 15750839, 15678618, 14021329, 13662844, 13663177, 13662997, 13663187, 13662877, 13660363, 13663214, 2264, 13662949, 13663037, 13662922, 13662988, 13658436, 13663064, 13608884, 13662998, 13663030, 13662833, 13663172, 13663130, 13194673, 13194565, 14855715, 14855832, 13553167, 13580782, 14708466, 13184675, 14363051, 14286744, 13177343, 13178014, 13159994, 13184528, 14351419, 13851507, 13184537, 13184590, 13184819, 14351436, 9929089, 13178138, 13322498, 4005563, 4007549, 13428655, 13428782, 14152325, 13744468, 13744594, 13744988, 12664724; Serviced/Repaired and Sold between July 10, 2020 and February 18, 2021 with Serial Numbers And No Bezel Ejector Pin Marks: 13957538, 12607700, 13061038, 13060510, 13069763, 13058882, 13061013, 13058475, 13061211, 13070091, 13059253, 13060693, 13070776, 13058970, 13060695, 13060750, 13060747, 13058622, 13061106, 13058766, 13056808, 13060877, 12667934, 13325198, 13495778, 12876247, 13107958, 13397686, 17569459, 13195488, 12766437, 14120311, 14114052, 14117289, 14124021, 14118083, 14122300, 14110517, 14120512, 14120591, 13058787, 13058835, 13070111, 1038662, 13058798, 14341505, 14321905, 14320652, 14321540, 14321606, 14321978, 14322006, 14321588, 14321576, 14321312, 14321218, 13058911, 13070275, 13058702, 13405025, 13061007, 13058778, 13057352, 13058590, 13066565, 13059200, 13058228, 13057843, 13059032, 13060749, 13212623, 13058009, 13057878, 13058596, 23060697, 23069352, 13060981, 13070780, 14201235, 13001035, 13405284, 13060796, 14200197, 13405142, 13058715, 14201234, 13212933, 13405301, 13125512, 13058523, 13060667, 13057898, 12580033, 13512515, 14064847, 13219417, 13220334, 14065848, 13219944, 13335903, 14061430, 14061166, 14064996, 13211175, 13208436, 13361187, 12869285, 12806211, 12589587, 13141802, 12764498, 4109662, 13219531, 13858686, 12672740, 14403241, 14070352, 12331567, 13066493, 13067292, 13070497, 13059192, 13069563, 15681457, 15037681, 15088020, 15344885, 13212921, 13069796, 13060558, 13067951, 13213139, 14357792, 14201398, 13404893, 13547403, 13057223, 13058307, 13069450, 13212589, 13058141, 13213318, 13061043, 13212706, 13205949, 13069585, 13205982, 13060863, 13057951, 13057946, 13070074, 13058909, 13069762, 13059031, 13060969, 12723827, 13061205, 13070212, 13059015, 12971125, 13058762, 13058855, 13061053, 13067233, 13067281, 13058754, 13060815, 13058799, 15037688, 12971413, 13066932, 13061174, 13067412, 13060958, 14308044, 14316727, 13976037, 13058826, 13060593, 13058794, 13405132, 13070112, 13058533, 14200709, 13060807, 13060653, 13060545, 13060895, 13061020, 13058561, 13060692, 13403978, 13070244, 13061225, 13070772, 13061188, 13058697, 13058800, 10938662, 13527491, 13069640, 13812730, 13068029, 15088022, 13070185, 13058050, 13061072, 13213069, 13058144, 13213097, 13070201, 13405352, 13060861, 13061176, 13219744, 13059183, 13125707, 13058861, 13058813, 13212585, 13069782, 12679928, 13070228, 13058560, 13060949, 13069349, 13739424, 14716904, 9952646, 9952897, 12666056, 12752058, 12752057, 12752008, 14321934, 14321229, 14321224, 14340821, 14337759, 14321605, 14320879, 13184045, 13212594, 13059196, 13057563, 13126061, 13059289, 13061161, 13058532, 13058468, 13058897, 13060706, 13055346, 13057517, 13059267, 14201336, 14440045, 13072976, 13058760, 13056721, 13061224, 13070731, 13069347, 13070116, 13060810, 13060974, 13058848, 13061051, 13061052, 13058002, 13124723, 13061131, 13015864, 13057312, 13060973, 13060655, 15035694, 13061078, 13058174, 13058918, 13408986, 13404355, 13746327, 15086257, 13070222, 14440148, 13070249, 13144661, 12606642, 12527638, 1385888, 13070816, 13060514, 13060659, 13058700, 13125847, 13058873, 13058834, 13060813, 13059228, 13060661, 13060829, 13059218, 13060912, 13058784, 13212513, 13060893, 13057320, 13060559, 13070817, 13212268, 13057960, 13059182, 13058880, 13059030, 13058749, 15087880, 13059249, 13060660, 13420636, 13060871, 13123029, 13058910, 13067998, 13069379, 13060534, 13061004, 13527473, 13405092, 13058789, 13059235, 13058626, 13058309, 13066447, 15037677, 13061186, 13058877, 13066727, 13060782, 13132330, 13060713, 13058802, 13058795, 13060997, 13060865, 13059016, 13827357, 13058627, 13061012, 13070778, 13404836, 13219964, 1306771, 13059179, 13060805, 13060712, 13061018, 13212815, 13058796, 13060536, 13058849, 13058546, 13060795, 13405172, 14200938, 13059172, 13070510, 15037700, 13404919, 13058913, 13058720, 13070186, 13069453, 13067771, 13123028, 13527627, 13059014, 13061191, 13212724	474
Z-1332-2021	Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410; Parts distributed between July 10, 2020 and January 22, 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers: 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, 267392	1494

Based on the official FDA remedy

What to do — step by step

Check Bezel for Cracks
Inspect the bezel for cracks or separation of posts, which could cause infusion issues.

Where it went and when

Where it was distributed

Distributed in 16 states.

FDA distribution: “US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Delaware, Florida, Kentucky, Louisiana, Maine, Minnesota, Missouri, Nevada, New York, North Carolina, Pennsylvania, Tennessee, Texas, Washington.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

Feb 25, 2021Firm started the recall
Apr 2, 2021FDA classified it Class I
Apr 14, 2021Published in FDA’s Enforcement Report
Aug 5, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/63228-tenacore-alaris-infusion-pump-8100-bezel-recall-cracking-risk">Tenacore Alaris Infusion Pump 8100 Bezel Recall: Cracking Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1332-2021 (February 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1332-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.