FDA Device recall Z-0188-2022
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989)…
- FDA Device
- Class II
- terminated
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989)… by 3m Health Care Business, citing potential for breakage of the ECG electrode carbon stud from the eyelet.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0188-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-06 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | 3m Health Care Business |
| Distribution | US |
Product
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.
Reason
Potential for breakage of the ECG electrode carbon stud from the eyelet.
Identifiers
| code_info | Lot #202302LK, Exp. 2023-02-19, pouch UDI (01)1070738789449(17)230219(11)202302LK, shipper box UDI (01)50707387789447(1…Lot #202302LK, Exp. 2023-02-19, pouch UDI (01)1070738789449(17)230219(11)202302LK, shipper box UDI (01)50707387789447(17)230219(11)202302LK Lot #202302LL, Exp. 2023-02-22, pouch UDI (01)1070738789449(17)230222(11)202302LL, shipper box UDI (01)50707387789447(17)230222(11)202302LL; Lot #202302LM, Exp. 2023-02-22, pouch UDI (01)1070738789449(17)230222(11)202302LM, shipper box UDI (01)50707387789447(17)230222(11)202302LM; Lot #202302LN, Exp. 2023-02-23. pouch UDI (01)1070738789449(17)230223(11)202302LN, shipper box UDI (01)50707387789447(17)230223(11)202302LN. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by 3m Health Care Business
- Clarity Precision Grip Attachments, for use in orthodontic treatment
FDA Device · Class II · 2025-01-01 · 3m Health Care Business - 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
FDA Device · Class II · 2024-10-16 · 3m Health Care Business - 3M Durapore Surgical Tape, Catalog Number 1538-118
FDA Device · Class II · 2024-05-01 · 3m Health Care Business - 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile
FDA Device · Class II · 2024-04-10 · 3m Health Care Business - 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
FDA Device · Class II · 2024-02-28 · 3m Health Care Business
All 3m Health Care Business recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0188-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.