CLASS III ONGOING Device recall · Reported 15 Feb 2023 · FDA Enforcement Report

MD Pulse III Multimodality System recalled by NuVasive

NuVasive is recalling NuVasive MD Pulse III Multimodality System, distributed nationwide in the US. The recall was initiated on 19 Jul 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesPart Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030

Quantity recalled7

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-1052-2023
FDA event ID: 91294
Recalling firm: NuVasive, San Diego, CA
Classification: Class III
Status: Ongoing
Recall initiated: 19 Jul 2022
FDA classified: 3 Feb 2023
Reported: 15 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

19 Jul 2022	Recall initiated by company
3 Feb 2023	Classified by FDA	+199 days
15 Feb 2023	Published in enforcement report	+12 days

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

Reason for recall

Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

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

NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

Where it was distributed

U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.

Nationwide California Florida North Carolina Ohio Texas

Questions about this recall

Is MD Pulse III Multimodality System recalled?

Yes. NuVasive recalled MD Pulse III Multimodality System on 19 Jul 2022. The recall is Class III and its status is Ongoing. Recall number Z-1052-2023.

Why was it recalled?

Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

Which lots are affected?

Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030

Where was it sold?

U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.

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 NuVasive

All 36

Reported	Class	Recall	Company	Reason	Where
28 Dec 2022Device	CLASS II	X-core 2 Ti Core, Static recalled by NuVasive	NuVasive	Other	Nationwide
3 Aug 2022Device	CLASS II	Description/Part: Simplify Disc Size 1, Ht 5/SM recalled by NuVasive	NuVasive	Lead & Heavy Metals	10 states
29 Jul 2020Device	CLASS II	NVM5 EMG Module recalled by NuVasive	NuVasive	Sterility	Nationwide
13 May 2020Device	CLASS II	Magec 2 Rod X.X mm XX mm recalled by NuVasive	NuVasive	Lead & Heavy Metals	Nationwide
28 Nov 2012Device	CLASS II	Screw Tulip Rod Subsequent Codes: KWP, KWQ, MNH, MNI recalled	NuVasive	Other	Nationwide

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide