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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86519

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 15, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
3M Company - Health Care Business

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).

Z-0419-2021
Recall number
Z-0419-2021
Initiated
September 15, 2020
Classification
Class II
Status
Terminated
Quantity
1,572,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Corrosion could cause performance failures in the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Corrosion could cause performance failures in the product.

Code information

Cat. No. V2560-5 (SKU: 70-2011-8381-4, SAP #: 7100205978). GTIN: 10707387788176 (pouch) and 50707387788174 (shipper) Lots: 202112EQ (Expiration 2021-12-09); 202201EA (Expiration 2022-01-01); 202205EH (Expiration 2022-05-14); and 202205EI (Expiration 2022-05-19)

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).

device · product 2 of 5

Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).

Z-0420-2021
Recall number
Z-0420-2021
Initiated
September 15, 2020
Classification
Class II
Status
Terminated
Quantity
156,600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Corrosion could cause performance failures in the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Corrosion could cause performance failures in the product.

Code information

Cat. No. V2560-3 (SKU: 70-2011-8380-6, SAP #: 7100205820). GTIN: 10707387788169 (pouch); 50707387788167 (shipper) Lots: 202201EB (Expiration 2022-01-01)

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).

device · product 3 of 5

3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).

Z-0421-2021
Recall number
Z-0421-2021
Initiated
September 15, 2020
Classification
Class II
Status
Terminated
Quantity
287,200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Corrosion could cause performance failures in the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Corrosion could cause performance failures in the product.

Code information

Cat. No. 2228BA (SKU: CH-0000-1642-8, SAP #: 7000032072). GTIN: 10707387582200 (pouch); 50707387786996 (shipper) Lots: 202204BA (Expiration 2020-04-20); 202204BB (Expiration 2020-04-22); 202204BC (Expiration 2020-04-27); 202204BD (Expiration 2020-04-28); 202204BE (Expiration 2020-04-29); 202204BF (Expiration 2020-04-30); 202204BG (Expiration 2020-05-04); 202204BH (Expiration 2020-05-05); 202204BI (Expiration 2020-05-07); 202204BJ (Expiration 2020-05-12); 202204BK (Expiration 2020-05-14); 202204BL (Expiration 2020-05-22); 202204BM (Expiration 2020-05-28); and 202204BN (Expiration 2020-06-02)

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).

device · product 4 of 5

3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).

Z-0422-2021
Recall number
Z-0422-2021
Initiated
September 15, 2020
Classification
Class II
Status
Terminated
Quantity
10,145,050 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Corrosion could cause performance failures in the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Corrosion could cause performance failures in the product.

Code information

Cat. No. 2228 (SKU: 70-2007-8021-4, SAP # 7100009333). GTIN: 10707387582200 (pouch) and 50707387786996 (shipper) Lots:202204LF (Expiration 2020-04-07); 202204LG (Expiration 2020-04-08); 202204LH (Expiration 2020-04-09); 202204LJ (Expiration 2020-04-13); 202204LK (Expiration 2020-04-13); 202204LL (Expiration 2020-04-14); 202204LM (Expiration 2020-04-15); 202204LN (Expiration 2020-04-16); 202204LP (Expiration 2020-04-17); 202204LQ (Expiration 2020-04-17); 202204LR (Expiration 2020-04-20); 202204LS (Expiration 2020-04-20); 202204LT (Expiration 2020-04-21); 202204LU (Expiration 2020-04-21); 202204LV (Expiration 2020-04-22); 202204LW (Expiration 2020-04-22); and 202204LY (Expiration 2020-04-24)

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).

device · product 5 of 5

3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).

Z-0423-2021
Recall number
Z-0423-2021
Initiated
September 15, 2020
Classification
Class II
Status
Terminated
Quantity
720,000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Corrosion could cause performance failures in the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Corrosion could cause performance failures in the product.

Code information

Cat. No. 2228 (SKU: 70-2011-8514-0, SAP # 7100212952). GTIN: 10707387789524 (pouch) and 50707387789522 (shipper) Lots: 202204MA (Expiration 2020-04-27)

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).