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Search recall evidence

Search official identifiers, recalled products, recalling firms, recall reasons, distribution language, and available device root-cause evidence.

Product, firm, identifier, or evidence phrase

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Ordinary terms are combined with AND. Put a literal phrase in quotation marks. Raw operators, wildcards, field syntax, and repeated controls are rejected.

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Results for “nationwide distribution”

35,881 true results · 25 per page

Events: 8,763
Products: 24,938
Firms: 2,180

Events

8,763 true total · 6 on this page

Recall event

Event 91321

91321

Matched recall reason

Recall reason · Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Represented date: November 28, 2022
Product type: Device
Classification: Class I
Matching products: 1

Recall event

Event 64782

64782

Matched recall reason

Recall reason · Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in …

Represented date: March 14, 2013
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 64453

64453

Matched recall reason

Recall reason · … As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead …

Represented date: March 01, 2013
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 85603

85603

Matched recall reason

Recall reason · The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution …

Represented date: April 23, 2020
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 88197

88197

Matched recall reason

Recall reason · Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational …

Represented date: June 03, 2021
Product type: Device
Classification: Class I
Matching products: 10

Recall event

Event 78155

78155

Matched recall reason

Recall reason · … is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.

Represented date: September 15, 2017
Product type: Drug
Classification: Class I
Matching products: 1

Products

24,938 true total · 14 on this page

Recalled product

Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

Z-0929-2023

Matched recall reason

Recall reason · Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Represented date: November 28, 2022
Product type: Device
Classification: Class I

Recalled product

Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.

Z-1111-2013

Matched recall reason

Recall reason · Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in …

Represented date: March 14, 2013
Product type: Device
Classification: Class II

Recalled product

Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.

Z-1028-2013

Matched recall reason

Recall reason · … As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead …

Represented date: March 01, 2013
Product type: Device
Classification: Class II

Recalled product

Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

Z-0204-2018

Matched recall reason

Recall reason · Distribution of unapproved devices with incorrect air compression level setup

Represented date: January 13, 2017
Product type: Device
Classification: Class II

Recalled product

ProxiDiagnost N90, UDI 706100

Z-2256-2020

Matched recall reason

Recall reason · The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution …

Represented date: April 23, 2020
Product type: Device
Classification: Class II

Recalled product

Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.

Z-1422-2017

Matched product description

Product description · … health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the …

Represented date: February 20, 2017
Product type: Device
Classification: Class II

Recalled product

Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

Z-1844-2024

Matched recall reason

Recall reason · The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may …

Represented date: May 03, 2024
Product type: Device
Classification: Class II

Recalled product

HeartWare HVAD Implant Kit, REF 1104JP

Z-2194-2021

Matched recall reason

Recall reason · Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational …

Represented date: June 03, 2021
Product type: Device
Classification: Class I

Recalled product

HeartWare HVAD Outflow Graft, REF MCS1725OG

Z-2196-2021

Matched recall reason

Recall reason · Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational …

Represented date: June 03, 2021
Product type: Device
Classification: Class I

Recalled product

HeartWare HVAD Pump Accessories, REF MCS1753AK

Z-2197-2021

Matched recall reason

Recall reason · Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational …

Represented date: June 03, 2021
Product type: Device
Classification: Class I

Recalled product

HeartWare HVAD Driveline Extension Cable, REF 100US

Z-2193-2021

Matched recall reason

Recall reason · Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational …

Represented date: June 03, 2021
Product type: Device
Classification: Class I

Recalled product

HeartWare HVAD Pump Implant Kit, REF 1153

Z-2191-2021

Matched recall reason

Recall reason · Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational …

Represented date: June 03, 2021
Product type: Device
Classification: Class I

Recalled product

HeartWare HVAD Pump Implant Kit, REF 1103

Z-2188-2021

Matched recall reason

Recall reason · Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational …

Represented date: June 03, 2021
Product type: Device
Classification: Class I

Recalled product

Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58

D-0030-2018

Matched recall reason

Recall reason · … is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.

Represented date: September 15, 2017
Product type: Drug
Classification: Class I

Firms

2,180 true total · 5 on this page

Firm

Edwards Lifesciences, LLC

edwards lifesciences llc

Matched recall reason

Recall reason · Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in …

Represented date: March 27, 2026
Product type: Device
Classification: Class II
Matching products: 49

Firm

Universal Meditech Inc.

universal meditech inc

Matched recall reason

Recall reason · Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Represented date: November 28, 2022
Product type: Device
Classification: Class I
Matching products: 1

Firm

Roche Diagnostics Operations, Inc.

roche diagnostics operations inc

Matched recall reason

Recall reason · … As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead …

Represented date: January 20, 2026
Product type: Device
Classification: Class II
Matching products: 87

Firm

Heartware, Inc.

heartware inc

Matched recall reason

Recall reason · Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational …

Represented date: May 16, 2023
Product type: Device
Classification: Class I
Matching products: 23

FDA name variants: Heartware, Inc. · HeartWare Inc · HeartWare, Inc

Firm

Baxter Healthcare Corporation

baxter healthcare corporation

Matched recall reason

Recall reason · … is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.

Represented date: May 21, 2026
Product type: Drug
Classification: Class I
Matching products: 212

FDA name variants: Baxter Healthcare Corporation · BAXTER HEALTHCARE CORPORATION