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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 281–300 of 1,000 recalls

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 →

Class IITerminated

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

Baxter Healthcare Corporation

Devices distributed lacked regulatory clearance.

February 25, 2022 · DeviceView details →

Class IITerminated

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

Baxter Healthcare Corporation

Product is mislabeled as self-righting Luer slip tip caps, yellow.

February 25, 2022 · DeviceView details →

Class IIITerminated

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

ROi CPS LLC

Recalled devices were packaged in convenience kits.

February 24, 2022 · DeviceView details →

Class IITerminated

(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.

Carefusion 2200 Inc

The finished device package did not contain the IFU.

February 23, 2022 · DeviceView details →

Class IITerminated

3.2MM Pellet Insertion Tray Catalog Number: B9743

Busse Hospital Disposables, Inc.

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

February 22, 2022 · DeviceView details →

Class IITerminated

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568

Busse Hospital Disposables, Inc.

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

February 22, 2022 · DeviceView details →

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