Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 1,001–1,050 of 7,959

• Medical Device Recall · January 30, 2026

  Tandem Diabetes Care, Inc.

  Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge,

  The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.

  Class II

• Medical Device Recall · January 30, 2026

  Covidien LLC

  HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 1

  Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

  Class II

• Medical Device Recall · January 30, 2026

  GE Medical Systems, LLC

  Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 58

  There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

  Class II

• Medical Device Recall · January 29, 2026

  Olympus Corporation of the Americas

  Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent ref

  Potential for rubber fragment detachment during use.

  Class II

• Medical Device Recall · January 29, 2026

  Olympus Corporation of the Americas

  Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent l

  Potential for rubber fragment detachment during use.

  Class II

• Medical Device Recall · January 29, 2026

  B Braun Medical Inc

  Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No

  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.

  Class II

• Medical Device Recall · January 29, 2026

  B Braun Medical Inc

  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 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.

  Class II

• Medical Device Recall · January 29, 2026

  B Braun Medical Inc

  Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Compone

  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.

  Class II

• Medical Device Recall · January 29, 2026

  B Braun Medical Inc

  Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP C

  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.

  Class II

• Medical Device Recall · January 29, 2026

  B Braun Medical Inc

  Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No

  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.

  Class II

• Medical Device Recall · January 29, 2026

  ReCor Medical Inc.

  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

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

  Class II

• Medical Device Recall · January 29, 2026

  B Braun Medical Inc

  Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No

  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.

  Class II

• Medical Device Recall · January 29, 2026

  B Braun Medical Inc

  Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No

  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.

  Class II

• Medical Device Recall · January 29, 2026

  ReCor Medical Inc.

  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

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

  Class II

• Medical Device Recall · January 29, 2026

  B Braun Medical Inc

  Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID

  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.

  Class II

• Medical Device Recall · January 28, 2026

  Medline Industries, LP

  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

  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.

  Class II

• Medical Device Recall · January 28, 2026

  Ultradent Products, Inc.

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

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

  Class II

• Medical Device Recall · January 28, 2026

  Medline Industries, LP

  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 MDTGXC

  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.

  Class II

• Medical Device Recall · January 27, 2026

  Abiomed, Inc.

  Impella RP Flex with SmartAssist. Product Code: 1000323.

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

  Class I

• Medical Device Recall · January 27, 2026

  Becton Dickinson & Company

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

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

  Class II

• Medical Device Recall · January 27, 2026

  Abiomed, Inc.

  Impella RP. Product Code: 0046-0011.

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

  Class I

• Medical Device Recall · January 27, 2026

  Lutronic Corporation

  CLARITY II Laser System; Model No. 1110200210.

  Reports of devices sparking/popping and potentially burning patients.

  Class II

• Medical Device Recall · January 27, 2026

  Abiomed, Inc.

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

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

  Class I

• Medical Device Recall · January 26, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

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

  Class II

• Medical Device Recall · January 26, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  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

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

  Class II

• Medical Device Recall · January 26, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  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

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

  Class II

• Medical Device Recall · January 26, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

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

  Class II

• Medical Device Recall · January 26, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  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

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

  Class II

• Medical Device Recall · January 26, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

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

  Class II

• Medical Device Recall · January 26, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

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

  Class II

• Medical Device Recall · January 26, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  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 Stabilizati

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

  Class II

• Medical Device Recall · January 23, 2026

  Datascope Corp.

  CS100 IABP. Software Version CS100 IABP Q.01.

  The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Strai

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-1

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-1

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  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, 31

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Arti

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16.

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 314

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301

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

  Class II

• Medical Device Recall · January 23, 2026

  Datascope Corp.

  CS300 IABP. Software Version CS300 IABP C.01.

  The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 2160

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

  Class II

• Medical Device Recall · January 23, 2026

  I.T.S. GmbH

  Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136

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

  Class II