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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 301–320 of 1,000 recalls

Class IIOngoing

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

Maquet Cardiopulmonary Gmbh

The packaging may not consistently maintain sterile barrier integrity.

July 31, 2026 · DeviceView details →
Class IIOngoing

JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L

Jenavalve Technology Inc.

Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

July 31, 2026 · DeviceView details →
Class IIOngoing

Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions

GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

July 31, 2026 · DeviceView details →
Class IIOngoing

Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Maquet Cardiopulmonary Gmbh

The packaging may not consistently maintain sterile barrier integrity.

July 31, 2026 · DeviceView details →
Class IIOngoing

Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A

Medline Industries, LP

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

July 31, 2026 · DeviceView details →
Class IIOngoing

JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M

Jenavalve Technology Inc.

Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

July 31, 2026 · DeviceView details →
Class IIOngoing

Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A

Medline Industries, LP

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

July 31, 2026 · DeviceView details →
Class IIOngoing

Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions

GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

July 31, 2026 · DeviceView details →
Class IIOngoing

SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25

WELL LEAD MEDICAL CO. LTD

The 6Fr suction catheter could not pass through the samples smoothly.

July 31, 2026 · DeviceView details →
Class IIOngoing

Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions

GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

July 31, 2026 · DeviceView details →
Class IIOngoing

Philips Patient Information Center iX REF:866389

Philips North America

Due to software malfunction, patient information system may freeze and become unresponsive.

July 31, 2026 · DeviceView details →
Class IIOngoing

Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions

GE Healthcare

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

July 31, 2026 · DeviceView details →
Class IIOngoing

JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S

Jenavalve Technology Inc.

Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

July 31, 2026 · DeviceView details →
Class IIOngoing

Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F

Medline Industries, LP

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

July 31, 2026 · DeviceView details →
Class IIOngoing

Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);

Maquet Cardiopulmonary Gmbh

The packaging may not consistently maintain sterile barrier integrity.

July 31, 2026 · DeviceView details →
Class IIOngoing

Convenience kits CATARACT PACK DYNJ59881A

Medline Industries, LP

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

July 31, 2026 · DeviceView details →
Class IIOngoing

Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000

Datex-Ohmeda, Inc.

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.

July 30, 2026 · DeviceView details →
Class IIOngoing

Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665

Datex-Ohmeda, Inc.

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.

July 30, 2026 · DeviceView details →
Class IIOngoing

Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV

GE Medical Systems Information Technologies Inc

Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

July 30, 2026 · DeviceView details →
Class IIOngoing

Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000

Datex-Ohmeda, Inc.

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.

July 30, 2026 · DeviceView details →
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