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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 381–400 of 1,000 recalls

Class IIOngoing

Innercool Coolblue Console, Model STx; Thermal regulating system.

Gentherm Medical, LLC

Overheating of the 115V CPU board may cause the device to shut down.

July 13, 2026 · DeviceView details →

Class IIOngoing

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

OBP Medical Corporation

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

July 13, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

AVID Medical, Inc.

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

GE Medical Systems Information Technologies Inc

A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B; 9) DIEP FLAP, Medline Kit SKU DYNJ910832A; 10) C-SECTION, Medline Kit SKU DYNJ911236; 11) LAPAROTOMY, Medline Kit SKU DYNJ911243; 12) OPEN HEART A&B, Medline Kit SKU DYNJ911245; 13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332; 14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330

Medline Industries, LP

Component labeling discrepancy

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I; 10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B; 11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B; 12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C; 13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180; 14) GYN ROBOTIC, Medline Kit SKU DYNJ910181; 15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A; 16) ROBOTICS, Medline Kit SKU DYNJ912062.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit SKU DYNJ903467L.

Medline Industries, LP

Kits contain a potentially contaminated component which were recalled by the manufacturer

July 10, 2026 · DeviceView details →

Class IIOngoing

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

July 9, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27

AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

July 9, 2026 · DeviceView details →

Class IIOngoing

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

AVID Medical, Inc.

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

July 9, 2026 · DeviceView details →

Class IIOngoing

Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Product Code 1481; Lot 2533123 4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of temporary crowns, bridges, inlays and onlays.

Henry Schein Inc.

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

July 9, 2026 · DeviceView details →

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