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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 4841–4860 of 39,430 recalls

Class IIOngoing

CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000

St. Jude Medical

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

October 5, 2024 · DeviceView details →
Class IIOngoing

CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000

St. Jude Medical

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

October 5, 2024 · DeviceView details →
Class IIOngoing

Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-000

Stryker Corporation

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

October 4, 2024 · DeviceView details →
Class IIOngoing

Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-046-001

Stryker Corporation

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

October 4, 2024 · DeviceView details →
Class IIOngoing

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723

Hobbs Medical, Inc.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

October 4, 2024 · DeviceView details →
Class IIOngoing

Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-001

Stryker Corporation

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

October 4, 2024 · DeviceView details →
Class IICompleted

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

Caire, Inc.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

October 4, 2024 · DeviceView details →
Class IIOngoing

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722

Hobbs Medical, Inc.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

October 4, 2024 · DeviceView details →
Class IIOngoing

Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-002

Stryker Corporation

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

October 4, 2024 · DeviceView details →
Class IIOngoing

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721

Hobbs Medical, Inc.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

October 4, 2024 · DeviceView details →
Class IIOngoing

CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A

MEDLINE INDUSTRIES, LP - Northfield

Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.

October 4, 2024 · DeviceView details →
Class IIOngoing

Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-046-000

Stryker Corporation

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

October 4, 2024 · DeviceView details →
Class IIOngoing

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718

Hobbs Medical, Inc.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

October 4, 2024 · DeviceView details →
Class IIOngoing

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716

Hobbs Medical, Inc.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

October 4, 2024 · DeviceView details →
Class IIOngoing

Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Catalog Number: 0703-046-002

Stryker Corporation

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

October 4, 2024 · DeviceView details →
Class IIOngoing

Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704

Hobbs Medical, Inc.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

October 4, 2024 · DeviceView details →
Class IIOngoing

ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C

MEDLINE INDUSTRIES, LP - Northfield

Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.

October 4, 2024 · DeviceView details →
Class IICompleted

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.

Caire, Inc.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

October 4, 2024 · DeviceView details →
Class IIOngoing

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702

Hobbs Medical, Inc.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

October 4, 2024 · DeviceView details →
Class IICompleted

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

Caire, Inc.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

October 4, 2024 · DeviceView details →
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