CLASS III Device recall · Reported 28 Jul 2021 · FDA Enforcement Report

3AA battery cradle recalled by Mindray DS USA

Mindray DS USA is recalling 3AA battery cradle (, distributed nationwide in the US. The recall was initiated on 27 May 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesPart Number 045-001699-01; Awaiting additional details

Quantity recalled804

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2108-2021
FDA event ID: 88209
Recalling firm: Mindray DS USA, Mahwah, NJ
Classification: Class III
Status: Terminated
Recall initiated: 27 May 2021
FDA classified: 21 Jul 2021
Reported: 28 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

27 May 2021	Recall initiated by company
21 Jul 2021	Classified by FDA	+55 days
28 Jul 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Telepack may not power on when using the 3AA battery cradle.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

Where it was distributed

Distributed US nationwide and Canada.

Nationwide

Questions about this recall

Is 3AA battery cradle ( recalled?

Yes. Mindray DS USA recalled 3AA battery cradle ( on 27 May 2021. The recall is Class III and its status is Terminated. Recall number Z-2108-2021.

Why was it recalled?

Telepack may not power on when using the 3AA battery cradle.

Which lots are affected?

Part Number 045-001699-01; Awaiting additional details

Where was it sold?

Distributed US nationwide and Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mindray DS USA

All 39

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Device	CLASS II	Hardware configuration of the BeneVision Central Monitoring recalled	Mindray DS USA	Device Malfunction	Nationwide
3 Dec 2025Device	CLASS II	The Anesthesia System is a device used to administer to recalled	Mindray DS USA	Packaging Defects	Nationwide
3 Dec 2025Device	CLASS II	The Anesthesia System is a device used to administer to recalled	Mindray DS USA	Packaging Defects	Nationwide
1 Oct 2025Device	CLASS II	BeneVision N1 Patient Monitor (N1) recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
11 Sep 2024Device	CLASS II	Sevoflurane E_Vap.(Quik-Fil):used recalled by Mindray DS USA	Mindray DS USA	Packaging Defects	Nationwide

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Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Digital ECG HD+12, HD+15 recalled by Midmark	Midmark	Labeling Errors	Nationwide