Browse Device Recalls
19 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 19 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 19 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 17, 2018 | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version... | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Ce... | Class II | Spacelabs Healthcare Inc |
| Oct 18, 2016 | Xhibit Central Station, Model 96102. Intended use is to provide clinicia... | The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. De... | Class II | Spacelabs Healthcare Inc |
| Aug 25, 2016 | Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xh... | The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In add... | Class II | Spacelabs Healthcare Inc |
| Aug 25, 2016 | Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Te... | The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In add... | Class II | Spacelabs Healthcare Inc |
| Jul 1, 2016 | 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/R... | The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becomi... | Class II | Spacelabs Healthcare Inc |
| Mar 28, 2016 | The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used... | Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), wh... | Class II | Spacelabs Healthcare Inc |
| Feb 26, 2016 | Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide c... | The firm has received one report of values for patient height and weight being switched when inpu... | Class II | Spacelabs Healthcare Inc |
| Sep 3, 2015 | Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80... | When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and i... | Class II | Spacelabs Healthcare Inc |
| May 8, 2015 | Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as e... | The input power can fail even though the power source at the wall has not been interrupted. In ad... | Class II | Spacelabs Healthcare Inc |
| Apr 21, 2015 | Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 01... | Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with... | Class II | Spacelabs Healthcare Inc |
| Apr 17, 2015 | Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 O... | Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was a... | Class II | Spacelabs Healthcare Inc |
| Jan 28, 2015 | Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs He... | Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has receiv... | Class II | Spacelabs Healthcare Inc |
| Jan 28, 2015 | Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs He... | Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has re... | Class II | Spacelabs Healthcare Inc |
| Aug 26, 2014 | Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Ar... | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. ... | Class II | Spacelabs Healthcare Inc |
| Jul 2, 2014 | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiologic... | The transmitter display and the Telemetry Central Station display may show a SpO2 value when the ... | Class II | Spacelabs Healthcare Inc |
| Jun 18, 2014 | Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.0... | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely... | Class II | Spacelabs Healthcare Inc |
| Jun 6, 2014 | Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert ... | Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of... | Class II | Spacelabs Healthcare Inc |
| May 9, 2014 | Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 | Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90... | Class II | Spacelabs Healthcare Inc |
| May 8, 2014 | Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia De... | A software anomaly causes temperature alarm limits to change to limits which are not physiologica... | Class II | Spacelabs Healthcare Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.