Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3330-2026%22

Class II recall Z-3330-2026: Tandem Diabetes Care, Inc.

Q: How to monitor Class II recall Z-3330-2026: Tandem Diabetes Care, Inc. and peer other records

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Class II recall Z-3330-2026: Tandem Diabetes Care, Inc. (California): Tandem Diabetes Care, Inc. Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-3330-2026
Recalling firm	Tandem Diabetes Care, Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
Reason	A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which could lead to users experiencing hypoglycemia or hyperglycemia.
Quantity	177
Distribution	US Nationwide distribution.
Recall initiated	2026-07-16
Reported	2026-10-07
Firm location	San Diego, CA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-07
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: Class II recall Z-3330-2026: Tandem Diabetes Care, Inc. and 76 California peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

California FDAPulse records like this one: 76
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 28 days ago.

What is the FDAPulse record for Class II recall Z-3330-2026: Tandem Diabetes Care, Inc. in California?

Class II device recall Z-3330-2026 by Tandem Diabetes Care, Inc.: A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing success

How does Class II recall Z-3330-2026: Tandem Diabetes Care, Inc. compare to other California FDAPulse records?

It is 28 days old, still within a typical 45-day follow-up window.

Class II recall Z-3330-2026 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-3330-2026	CA	2026-10-07
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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