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…
Read the official notice →- Date
- 2025-09-03
- Country
- United States
- Brand
- Tandem Diabetes Care
- Product
- Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished,…
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-11-12
USTandem Diabetes Care, Inc. recalls Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and…
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot…
FDA · DeviceTandem Diabetes Care, Inc.US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →- 2025-10-29
- US
Tandem 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 → - 2025-04-23
- 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 → - 2022-10-05
- US
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…
FDA · DeviceTandem Diabetes Care IncUS: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC,…Official notice →
Other drugs & medical recalls in the United States
- 2025-09-03
- US
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The…
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
FDA · DeviceTHOR Photomedicine LtdWorldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID,…Official notice → - US
Baxter Healthcare Corporation recalls Spectrum IQ Infusion Pump, Product Code 3570009
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having…
- US
Philips Ultrasound, Inc recalls TRANSDUCER L12-5 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- US
GE Medical Systems, LLC recalls GE HealthCare OEC 9900 Elite C-arm Systems.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator…
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428,…
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- US
Lannett Company Inc. recalls Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136.…
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.