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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 2601–2620 of 39,430 recalls

Class IIOngoing

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

Aesculap AG

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

August 18, 2025 · DeviceView details →
Class IIOngoing

Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

Maquet Cardiovascular, LLC

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

August 15, 2025 · DeviceView details →
Class IIOngoing

Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

Exactech, Inc.

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

August 15, 2025 · DeviceView details →
Class IIOngoing

Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.

Maquet Cardiovascular, LLC

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

August 15, 2025 · DeviceView details →
Class IIOngoing

BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

Mindray DS USA, Inc. dba Mindray North America

Potential for activation of an abnormal alarm pause.

August 15, 2025 · DeviceView details →
Class IIOngoing

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.

ETHICON, LLC

Potential for barb non-engagement.

August 15, 2025 · DeviceView details →
Class IIOngoing

Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/

Exactech, Inc.

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

August 15, 2025 · DeviceView details →
Class IIOngoing

Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.

Maquet Cardiovascular, LLC

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

August 15, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 360020-1P

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIOngoing

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Beckman Coulter Inc.

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIIOngoing

Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

Penner Patient Care, Inc.

The device does not bear a unique device identifier.

August 13, 2025 · DeviceView details →
Class IIOngoing

Change Healthcare Radiology Solutions software version 14.2.2

CHANGE HEALTHCARE CANADA COMPANY

Due to software issue, radiology reports may not be fully displayed when viewing.

August 13, 2025 · DeviceView details →
Class IIOngoing

Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

August 13, 2025 · DeviceView details →
Class IIOngoing

iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

Beta Bionics, Inc.

it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.

August 13, 2025 · DeviceView details →
Class IIOngoing

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

August 13, 2025 · DeviceView details →
Class IIOngoing

Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

August 13, 2025 · DeviceView details →
Class IIOngoing

Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

August 13, 2025 · DeviceView details →
Class IIOngoing

UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

Beckman Coulter Inc.

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

August 13, 2025 · DeviceView details →
Class IIOngoing

Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

Philips North America Llc

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

August 13, 2025 · DeviceView details →
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