Tandem Diabetes Care Inc recalls 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…
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…
Read the official notice →- Date
- 2022-10-05
- Country
- United States
- 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…
- Classification
- Class II
- Units
- US: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Tandem Diabetes Care recalls
- 2025-10-29
USTandem Diabetes Care, Inc. recalls t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide…
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an…
FDA · DeviceTandem Diabetes Care, Inc.US nationwide distribution including Puerto Rico.Official notice →- 2025-10-01
- US
Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent…
FDA · DeviceTandem Diabetes Care, Inc.International distribution to the country of Israel.Official notice → - 2025-09-03
- US
Tandem Diabetes Care, Inc. recalls Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished,…
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in…
FDA · DeviceTandem Diabetes Care, Inc.Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech…Official notice → - 2025-04-23
- US
Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated…
FDA · DeviceTandem Diabetes Care, Inc.US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE,…Official notice → - 2024-05-15
- US
Tandem Diabetes Care, Inc. recalls t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result…
FDA · DeviceTandem Diabetes Care, Inc.US nationwide distribution including Puerto Rico.Official notice → - 2022-06-22
- US
Tandem Diabetes Care Inc recalls t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will…
FDA · DeviceTandem Diabetes Care IncInternational distribution in the country of Australia.Official notice →
Other drugs & medical recalls in the United States
- 2022-10-05
- US
Baxter Healthcare Corporation recalls Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts…
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide Distribution and government/military distribution.Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwided Foreign: Afghanistan¿¿¿¿ Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…Official notice → - US
Olympus Corporation of the Americas recalls Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device…
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
FDA · DeviceOlympus Corporation of the AmericasNationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREAOfficial notice → - US
Unomedical A/S recalls Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with…
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
FDA · DeviceUnomedical A/SDistribution was made to California. There was no government/military…Official notice → - US
Mckesson Medical-Surgical Inc. Corporate Office recalls SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
FDA · DeviceMckesson Medical-Surgical Inc. Corporate OfficeUS Nationwide distribution.Official notice → - US
Micro-X Ltd. recalls MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions
FDA · DeviceMicro-X Ltd.Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV,…Official notice →