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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1–20 of 25 recalls

Class IIIOngoing

ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A

Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

August 31, 2026 · DeviceView details →

Class IIIOngoing

BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.

Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

August 31, 2026 · DeviceView details →

Class IIIOngoing

Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).

Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

August 31, 2026 · DeviceView details →

Class IIIOngoing

BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80

Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

August 31, 2026 · DeviceView details →

Class IIIOngoing

cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12

Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

August 31, 2026 · DeviceView details →

Class IIIOngoing

BeneView Series. Operator's Manuals: T5 / T8

Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

August 31, 2026 · DeviceView details →

Class IIIOngoing

T1 Patient Monitor. Operator's Manual: T1 Patient Monitor

Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

August 31, 2026 · DeviceView details →

Class IIIOngoing

Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V

Mindray DS USA, Inc.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

August 31, 2026 · DeviceView details →

Class IIIOngoing

HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069

HeartSine Technologies Ltd

Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

July 27, 2026 · DeviceView details →

Class IIIOngoing

Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

Paragon 28, Inc.

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

July 10, 2026 · DeviceView details →

Class IIIOngoing

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant

Paragon 28, Inc.

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

July 10, 2026 · DeviceView details →

Class IIIOngoing

Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A

Medical Action Industries, Inc. 306

An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

July 9, 2026 · DeviceView details →

Class IIIOngoing

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

Siemens Healthcare Diagnostics, Inc.

out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

June 26, 2026 · DeviceView details →

Class IIIOngoing

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Siemens Healthcare Diagnostics, Inc.

Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

June 26, 2026 · DeviceView details →

Class IIIOngoing

Heraeus, PALAMIX uno. Material Number: 66057893.

Heraeus Medical GmbH (Dental Division)

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

March 25, 2026 · DeviceView details →

Class IIIOngoing

Heraeus, PALAMIX duo. Material Number: 66057897.

Heraeus Medical GmbH (Dental Division)

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

March 25, 2026 · DeviceView details →

Class IIIOngoing

Battery Charging Station; Model: 0998-00-0802;

Datascope Corp.

The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

February 6, 2026 · DeviceView details →

Class IIIOngoing

WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

Straumann USA LLC

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.

January 6, 2026 · DeviceView details →

Class IIIOngoing

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Instrumentation Laboratory

Recalled lots were manufactured with double the amount of preservative concentration.

November 18, 2025 · DeviceView details →

Class IIIOngoing

Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;

Orthofix U.S. LLC

Labeling contains claims that are not consistently present.

November 3, 2025 · DeviceView details →

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