FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

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 IITerminated

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

DIXI MEDICAL USA

Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

December 9, 2021 · DeviceView details →

Class IITerminated

Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

Technomed Europe

There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

December 8, 2021 · DeviceView details →

Class IITerminated

R82 by ETAC Push Brace for High-Low

R82 A/S

The chrome surface of the push brace can crack during use, potentially cutting the user.

December 8, 2021 · DeviceView details →

Class IITerminated

AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

Beckman Coulter Inc.

Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.

December 8, 2021 · DeviceView details →

Class IITerminated

GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600

DePuy Orthopaedics, Inc.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

December 7, 2021 · DeviceView details →

Class IITerminated

GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

DePuy Orthopaedics, Inc.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

December 7, 2021 · DeviceView details →

Class IITerminated

GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

DePuy Orthopaedics, Inc.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

December 7, 2021 · DeviceView details →

Class IITerminated

GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

DePuy Orthopaedics, Inc.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

December 7, 2021 · DeviceView details →

Class IITerminated

GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600

DePuy Orthopaedics, Inc.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

December 7, 2021 · DeviceView details →

Class IITerminated

GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

DePuy Orthopaedics, Inc.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

December 7, 2021 · DeviceView details →

Class IITerminated

GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

DePuy Orthopaedics, Inc.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

December 7, 2021 · DeviceView details →

Class IITerminated

GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100

DePuy Orthopaedics, Inc.

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

December 7, 2021 · DeviceView details →

Class IITerminated

LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

Covidien Llc

Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.

December 6, 2021 · DeviceView details →

Class IITerminated

Alinity m System, Part No. 08N53-002

Abbott Molecular, Inc.

There is an issue with the installation of updated camera firmware on the system.

December 6, 2021 · DeviceView details →

Class IITerminated

ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC

Konica Minolta Healthcare Americas, Inc.

lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed

December 3, 2021 · DeviceView details →

Class IITerminated

Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)

LivaNova USA, Inc.

A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.

December 2, 2021 · DeviceView details →

Class IITerminated

IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.

December 2, 2021 · DeviceView details →

Class IITerminated

Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635

Siemens Healthcare Diagnostics, Inc.

¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L

December 1, 2021 · DeviceView details →

Class IITerminated

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Maquet Cardiovascular, LLC

There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

December 1, 2021 · DeviceView details →

Class IITerminated

HARDY DIAGNOSTICS CatScreen, 25dsk/vial

MEDLINE INDUSTRIES, LP - Northfield

Product stored incorrectly in temperature controlled setting instead of refrigeration.

December 1, 2021 · DeviceView details →

← PreviousPage 20 of 50Next →