Know when a medical device receives a recall or safety warning

Search recalls and safety notices, follow the products you rely on, and reach the correct official reporting channel when something goes wrong.

Source-backed medical safety information. Not medical advice.

Latest recall records

Owner-reviewed recent FDA events, consolidated by recall action. Each links to its official source.

All recalls

Class I recallOngoing

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallOngoing

EMPOWR 3D KNEE INS, 11L 14MM, VE recall — FDA event 98700

Due to packaging discrepancy with incorrect product size mixed up.

FDA · FDA event 98700Posted Jul 8, 2026

Class II recallOngoing

MiniMed 780G Insulin Pump recall — FDA event 99207

A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23.…

FDA · FDA event 99207Posted Jul 8, 2026

Browse reviewed categories

V1 category definitions are approved; counts reflect the current reviewed public dataset.

All devices

How MedWatcher works

Step 1
We monitor official sources
MedWatcher checks U.S. FDA recall and enforcement records. Official manufacturer pages are checked manually for device identity.
Step 2
Records are normalized and explained
Each record keeps its source agency, identifier, and dates, with a plain-English summary of what happened and who may be affected.
Step 3
Follow the products you use
Follow a device, manufacturer, or category to preview how email alerts will work when a new record appears.
Step 4
Reach the right reporting channel
If something goes wrong with a product, our reporting navigator points you to the correct official destination.

Popular devices

Browse all

Abbott Assurity MRI Pacemaker

Abbott · Pacemakers

No recall records found

Last checked Aug 17, 2026

Abbott Aveir DR Leadless Pacemaker System

Abbott · Pacemakers

No recall records found

Last checked Aug 17, 2026

B. Braun Infusomat Space Infusion Pump

B. Braun Medical Inc. · Infusion pumps

No recall records found

Last checked Aug 17, 2026

Baxter SIGMA Spectrum Infusion System

Baxter Healthcare Corporation · Infusion pumps

Active recall record

Last checked Oct 8, 2026

BD Alaris Infusion System

Becton, Dickinson and Company · Infusion pumps

Active recall record

Last checked Oct 8, 2026

BIOTRONIK Amvia Sky Pacemaker

BIOTRONIK SE & Co. KG · Pacemakers

No recall records found

Last checked Aug 17, 2026

Did something go wrong with a medical product?

MedWatcher does not collect incident reports. Our reporting navigator asks a few questions and points you to the correct official channel in the United States or Canada, along with the information to gather first.

Find the official reporting channel

Latest guides

All guides

What medical-device recall classifications mean

How FDA recall classifications describe the risk of a specific recall action, and why they do not tell you what to do with your own device.

Updated Aug 23, 2026 · 5 min read

How to respond to a medical-device recall

A source-first way to check whether a notice applies to your device and to find the action stated in the official notice.

Updated Aug 23, 2026 · 6 min read

How to find device, serial, and lot identifiers

What the FDA calls device and production identifiers, and how to use the exact identifier requested by an official notice.

Updated Aug 23, 2026 · 4 min read

How to read a recall notice for an implanted device

How to distinguish a regulator record from a personal care decision, and the details to bring to the clinician who manages your implant.

Updated Aug 23, 2026 · 4 min read

How to read a medical-device recall record

A plain-language guide to the fields in an official recall record: the affected product, the reason, the action, and the status.

Updated Aug 23, 2026 · 5 min read

Recall, early alert, or safety communication?

Why MedWatcher keeps these official notices distinct and uses the status supplied by the regulator instead of inferring one.

Updated Aug 23, 2026 · 4 min read

Loading MedWatcher information…

Know when a medical device receives a recall or safety warning

Search recalls and safety notices, follow the products you rely on, and reach the correct official reporting channel when something goes wrong.

Source-backed medical safety information. Not medical advice.

Latest recall records

Owner-reviewed recent FDA events, consolidated by recall action. Each links to its official source.

All recalls

Class I recallOngoing

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallOngoing

EMPOWR 3D KNEE INS, 11L 14MM, VE recall — FDA event 98700

Due to packaging discrepancy with incorrect product size mixed up.

FDA · FDA event 98700Posted Jul 8, 2026

Class II recallOngoing

MiniMed 780G Insulin Pump recall — FDA event 99207

FDA · FDA event 99207Posted Jul 8, 2026

Browse reviewed categories

V1 category definitions are approved; counts reflect the current reviewed public dataset.

All devices

How MedWatcher works

Step 1
We monitor official sources
MedWatcher checks U.S. FDA recall and enforcement records. Official manufacturer pages are checked manually for device identity.
Step 2
Records are normalized and explained
Each record keeps its source agency, identifier, and dates, with a plain-English summary of what happened and who may be affected.
Step 3
Follow the products you use
Follow a device, manufacturer, or category to preview how email alerts will work when a new record appears.
Step 4
Reach the right reporting channel
If something goes wrong with a product, our reporting navigator points you to the correct official destination.