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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 201–220 of 1,000 recalls

Class IITerminated

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

Siemens Medical Solutions USA, Inc.

There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.

March 11, 2022 · DeviceView details →

Class IITerminated

EasyFuse Dynamic Compression System Instrument Pack

Wright Medical Technology, Inc.

The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

March 10, 2022 · DeviceView details →

Class IITerminated

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

MEDLINE INDUSTRIES, LP - Northfield

The mask cuff may disconnect from the device's breathing tube.

March 9, 2022 · DeviceView details →

Class IITerminated

BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

Becton Dickinson & Co.

When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.

March 9, 2022 · DeviceView details →

Class IITerminated

RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.

Roche Diabetes Care, Inc.

Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.

March 9, 2022 · DeviceView details →

Class IITerminated

Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.

MEDLINE INDUSTRIES, LP - Northfield

The product was stored incorrectly due to improper storage controls which may lead to delayed results.

March 8, 2022 · DeviceView details →

Class IITerminated

Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

MEDLINE INDUSTRIES, LP - Northfield

Product was improperly store which may cause a delay in results.

March 8, 2022 · DeviceView details →

Class IITerminated

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Siemens Medical Solutions USA, Inc

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

March 7, 2022 · DeviceView details →

Class IITerminated

syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Siemens Medical Solutions USA, Inc

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

March 7, 2022 · DeviceView details →

Class IITerminated

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Siemens Medical Solutions USA, Inc

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

March 7, 2022 · DeviceView details →

Class IITerminated

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Siemens Medical Solutions USA, Inc

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

March 7, 2022 · DeviceView details →

Class IITerminated

First SIGN SARS-CoV-2 Antigen Test

WHPM Inc.

Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution in the U.S.

March 4, 2022 · DeviceView details →

Class IITerminated

Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

MEDLINE INDUSTRIES, LP - Northfield

Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

March 4, 2022 · DeviceView details →

Class IITerminated

DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

DeRoyal Industries Inc

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

March 3, 2022 · DeviceView details →

Class IITerminated

DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

DeRoyal Industries Inc

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

March 3, 2022 · DeviceView details →

Class IITerminated

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

Microbiologics Inc

Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

March 3, 2022 · DeviceView details →

Class IITerminated

DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

DeRoyal Industries Inc

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

March 3, 2022 · DeviceView details →

Class IITerminated

First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)

ASO LLC

Kits contained recalled acetaminophen.

March 2, 2022 · DeviceView details →

Class IITerminated

Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

Resource Optimization & Innovation LLC

A kit component, the PDI Prevantics Swab, was recalled.

February 28, 2022 · DeviceView details →

Class IITerminated

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Microbiologics Inc

Distributed product did not undergo proper release testing.

February 25, 2022 · DeviceView details →

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