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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 401–420 of 1,000 recalls

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 II

Ongoing

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 →

Class IIOngoing

Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D; 5) NEURO PACK, Medline Kit SKU DYNJ45121I; 6) NEURO LAMINECTOMY PACK, Medline Kit SKU DYNJ58012A; 7) NEURO PACK SJ, Medline Kit SKU DYNJ63477A; 8) BASIC NEURO PACK, Medline Kit SKU DYNJ83071A.

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 →

Class IIOngoing

Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.

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 →

Class IIOngoing

Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131

Fort Defiance Industries, LLC

The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.

July 8, 2026 · DeviceView details →

Class IIOngoing

Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.

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 →

Class IIOngoing

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

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

FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.

INTEGRATED MEDCRAFT LLC

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

July 7, 2026 · DeviceView details →

Class IIOngoing

Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.

INTEGRATED MEDCRAFT LLC

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

July 7, 2026 · DeviceView details →

Class IIOngoing

Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.

Olympus Corporation of the Americas

Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.

July 7, 2026 · DeviceView details →

Class IIOngoing

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Siemens Healthcare Diagnostics, Inc.

Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

July 6, 2026 · DeviceView details →

Class IIOngoing

Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

PI CARDIA LTD

Transfemoral catheter, positing arm may detached due to weld issue.

July 6, 2026 · DeviceView details →

Class IIOngoing

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.

ConvaTec, Inc

Urostomy Pouches may leak from cap during use.

July 6, 2026 · DeviceView details →

Class IIOngoing

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

Waldemar Link GmbH & Co. KG (Mfg Site)

The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

July 6, 2026 · DeviceView details →

Class IIOngoing

OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095

IsoTis OrthoBiologics, Inc.

Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.

July 2, 2026 · DeviceView details →

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