Use caution Medical device recall · FDA · Published May 24, 2022

Tandem Diabetes Care t:slim X2 Insulin Pump Recall: Hypoglycemia Risk

Tandem Diabetes Care recalls t:slim X2 insulin pumps with specific software versions due to potential hypoglycemia, hyperglycemia, or diabetic ketoacidosis risks from malfunctioning features.

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

🇺🇸 FDA recall #Z-1811-2022Medical device Tandem Diabetes Care ›

Use caution until it’s fixed

Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.

Take action

Contact the company

Recalling firmTandem Diabetes Care Inc11075 Roselle St · San Diego, CA 92121-1204

✎ GovInfoNow plain-language explainer

Tandem Diabetes Care is recalling certain t:slim X2 insulin pumps that may malfunction, leading to incorrect blood sugar readings or other issues that could cause dangerous low or high blood sugar levels. This recall is important for people using these pumps to prevent serious health complications. Read more at govinfonow.com/recall/60665-tandem-diabetes-care-t-slim-x2-insulin-pump-recall-hypoglycemia.

Source Summary by GovInfoNow · govinfonow.com/recall/60665-tandem-diabetes-care-t-slim-x2-insulin-pump-recall-hypoglycemia · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1811-2022

Cite this page

“Tandem Diabetes Care t:slim X2 Insulin Pump Recall: Hypoglycemia Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60665-tandem-diabetes-care-t-slim-x2-insulin-pump-recall-hypoglycemia. Based on FDA recall #Z-1811-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1811-2022%22&limit=1).

The FDA announced on May 24, 2022, that Tandem Diabetes Care is recalling t:slim X2 insulin pumps due to software issues that could cause hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Tandem Diabetes Care
Product: t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Quantity: 31,100 units

The hazard

The pumps may experience malfunctioning non-volatile memory, inaccurate battery life display, a touchscreen staying on, or unexpected open loop conditions. These issues can be mitigated with a software update but could result in hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Context

GovInfoNow's records show Tandem Diabetes Care has had 10 other recalls since April 23, 2018. Recent brand issues include a July 16, 2026 pairing issue with Abbott sensors and an Oct. 6, 2025 false vibration motor failure risk in the Mobi pump. Other recent recalls of similar products include Medtronic MiniMed 620G Insulin Pump Recall (Feb. 13, 2026), Medtronic MiniMed 770G Insulin Pump Recall (Feb. 13, 2026), and Medtronic MiniMed 740G Insulin Pump Recall (Feb. 13, 2026).

How to tell if you have this one

Check your pump's software version and serial number. The recall includes specific model numbers and software versions listed in the product details. Contact Tandem Diabetes Care if you have one of these models.

Brand
Tandem Diabetes Care
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 II
Status
Ongoing
Distribution
US: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC, MS, GA, NV, HI, MN, WA, IN, AR, ID, CO, IA, MO, MT, PA, WI, NH, MD, WV, KS, NM, OR, KY, DE, ND, CT, NJ, TN, WY, AK, SD, DC, RI, IA, PR, VT, PT, VI, NC. OUS: Australia, New Zealand, South Africa

Recall number	Product, codes & lots	Quantity
Z-1811-2022	t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology; Pump/UDI-DI/Software Versions/Distributor Instructions: t:slim X2 insulin pump/00852162004781, 00852162004798, 00853052007240/ 4.3.5.2, 4.3.6/ For Distributors, All Parts, Contact Recalling Firm to Switch Out; t:slim X2 insulin pump with Dexcom G5/853052007257, 853052007271, 853052007295, 853052007318, 853052007967, 853052007981/ 5.0.1, 5.0.4, 5.3.1.1/ For Distributors, All Parts, Contact Recalling Firm to Switch Out; t:slim X2 insulin pump with Basal-IQ technology/853052007264, 853052007288, 853052007301, 853052007325, 850006613373, 850006613380, 850006613700, 850006613717, 850006613724, 850006613731/ 6.0.4, 6.3.1.1, 6.4/ For Distributors: 1) Parts: 1000886, 1000898, 1004219, 1005706, 1006373 or 1006375, Contact Recalling Firm to Switch Out, 2) Parts: 1010004, 1010005,1010006, No Action Required, Software is Up to Date; t:slim X2 insulin pump with Control-IQ technology/ 850006613229, 850006613205, 850006613212, 850006613762, 850006613779, 850006613786, 850006613793/ 7.3.1.1, 7.4/ For Distributors: 1) Parts: 1005011, 1005012, 1006402 or 1006404, Contact Recalling Firm to Switch Out, 2) Parts: 1010009,1010010, 1010011, No Action Required, Software is Up to Date	31,100
Z-1812-2022	t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology; Insulin Pump/Software Versions: t:slim X2 insulin pump/6.4.1 and earlier; t:slim X2 insulin pump with Dexcom G5/5.2.1, 5.2.2; t:slim X2 insulin pump with Basal-IQ technology/6.3.0.1, 6.4, 6.4.1; t: slim x2 insulin pump with the Control-IQ Technology/7.4, 7.4.3	8399

Based on the official FDA remedy

What to do — step by step

Check Pump Software Version
Review your pump's software version and serial number to see if it matches the recalled models listed in the notice.
Contact Tandem Diabetes Care
If your pump is listed, contact Tandem Diabetes Care to arrange a switch-out or software update.

Where it went and when

Where it was distributed

Distributed in 50 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC, MS, GA, NV, HI, MN, WA, IN, AR, ID, CO, IA, MO, MT, PA, WI, NH, MD, WV, KS, NM, OR, KY, DE, ND, CT, NJ, TN, WY, AK, SD, DC, RI, IA, PR, VT, PT, VI, NC. OUS:…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 4 months after the firm started it.

May 24, 2022Firm started the recall
Sep 26, 2022FDA classified it Class II
Oct 5, 2022Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any parts that need replacing?

Yes, specific parts like 1000886, 1000898, 1004219, 1005706, 1006373, or 1006375 may need replacement if your pump is listed, but some parts require no action if the software is up to date.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/60665-tandem-diabetes-care-t-slim-x2-insulin-pump-recall-hypoglycemia">Tandem Diabetes Care t:slim X2 Insulin Pump Recall: Hypoglycemia 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-1811-2022 (May 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1811-2022 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.