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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 441–460 of 1,000 recalls

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 →
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

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

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

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

Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065 3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099 4) 949-3597, Mfr Product Code 1843; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures.

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 →
Class IIOngoing

TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

Tobii Dynavox Llc

Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.

July 8, 2026 · DeviceView details →
Class IIOngoing

Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; 13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; 14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.

Medline Industries, LP

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

July 8, 2026 · DeviceView details →
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