Class II — Medtronic Inc.
| Recalling firm | Medtronic, Inc. |
|---|---|
| Registered facility | View this company's 53 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher. |
| Product | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRG… |
| Quantity | 18788 units |
| Distribution | Worldwide distribution. |
| Initiated | 2024-07-11 |
| Classified | 2024-09-13 |
| Recall number | Z-3152-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic Inc. (Z-3152-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95176/
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