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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 4221–4240 of 39,430 recalls

Class IIOngoing

Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

Oxoid Limited

Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.

December 23, 2024 · DeviceView details →
Class IICompleted

CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Accuray Incorporated

Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.

December 23, 2024 · Device
View details →
Class IIOngoing

AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,

Hollister Incorporated

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

December 23, 2024 · DeviceView details →
Class IIOngoing

AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,

Hollister Incorporated

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

December 23, 2024 · DeviceView details →
Class IOngoing

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Baxter Healthcare Corporation

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

December 20, 2024 · DeviceView details →
Class IIOngoing

AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →
Class IIOngoing

PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.

Ethicon, LLC

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

December 20, 2024 · DeviceView details →
Class IIOngoing

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →
Class IIOngoing

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →
Class IIOngoing

Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519

Baxter Healthcare Corporation

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

December 20, 2024 · DeviceView details →
Class IIOngoing

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →
Class IIOngoing

ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

Ethicon, LLC

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

December 20, 2024 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.

December 20, 2024 · DeviceView details →
Class IIOngoing

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →
Class IOngoing

Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Baxter Healthcare Corporation

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

December 20, 2024 · DeviceView details →
Class IIOngoing

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →
Class IIOngoing

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

Randox Laboratories, Limited

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

December 20, 2024 · DeviceView details →
Class IIOngoing

AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →
Class IIOngoing

AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

Boston Scientific Corporation

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

December 20, 2024 · DeviceView details →
Class IIOngoing

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

Randox Laboratories, Limited

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

December 20, 2024 · DeviceView details →
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