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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 1081–1100 of 39,430 recalls

Class IIOngoing

Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation

ReCor Medical Inc.

Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

January 29, 2026 · DeviceView details →
Class IIOngoing

Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No

B Braun Medical Inc

B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

January 29, 2026 · Device
View details →
Class IIOngoing

Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

Ultradent Products, Inc.

Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.

January 28, 2026 · DeviceView details →
Class IIOngoing

Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL

Medline Industries, LP

Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

January 28, 2026 · DeviceView details →
Class IIOngoing

Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT

Medline Industries, LP

Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

January 28, 2026 · DeviceView details →
Class IOngoing

Impella RP Flex with SmartAssist. Product Code: 1000323.

Abiomed, Inc.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

January 27, 2026 · DeviceView details →
Class IOngoing

Impella RP with SmartAssist. Product Code: 0046-0035.

Abiomed, Inc.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

January 27, 2026 · DeviceView details →
Class IOngoing

Impella RP. Product Code: 0046-0011.

Abiomed, Inc.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

January 27, 2026 · DeviceView details →
Class IIOngoing

10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.

Becton Dickinson & Company

During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

January 27, 2026 · DeviceView details →
Class IIOngoing

CLARITY II Laser System; Model No. 1110200210.

Lutronic Corporation

Reports of devices sparking/popping and potentially burning patients.

January 27, 2026 · DeviceView details →
Class IIOngoing

Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026 · DeviceView details →
Class IIOngoing

Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026 · DeviceView details →
Class IIOngoing

Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026 · DeviceView details →
Class IIOngoing

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026 · DeviceView details →
Class IIOngoing

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026 · DeviceView details →
Class IIOngoing

Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026 · DeviceView details →
Class IIOngoing

Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026 · DeviceView details →
Class IIOngoing

Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

January 26, 2026 · DeviceView details →
Class IIOngoing

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

I.T.S. GmbH

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

January 23, 2026 · DeviceView details →
Class IIOngoing

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

I.T.S. GmbH

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

January 23, 2026 · DeviceView details →
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