Current FDA corpus

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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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 76046

76046

Matched product description

Product description · … Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all …

Represented date: October 06, 2016
Product type: Device
Classification: Class II
Matching products: 2

Recall event

Event 93546

93546

Matched recall reason

Recall reason · … Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot …

Represented date: November 30, 2023
Product type: Device
Classification: Class I
Matching products: 3

Recall event

Event 75992

75992

Matched recall reason

Recall reason · … out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time …

Represented date: December 14, 2016
Product type: Drug
Classification: Class III
Matching products: 1

Recall event

Event 94508

94508

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
Matching products: 30

Recall event

Event 68282

68282

Matched recall reason

Recall reason · Failed Stability Specification; out of specification result for particle size distribution during stability testing

Represented date: May 28, 2014
Product type: Drug
Classification: Class III
Matching products: 1

Recall event

Event 94928

94928

Matched product description

Product description · … It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the …

Represented date: May 27, 2024
Product type: Device
Classification: Class II
Matching products: 3

Products

24,938 true total · 15 on this page

Recalled product

SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.

Z-1097-2017

Matched product description

Product description · … Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all …

Represented date: October 06, 2016
Product type: Device
Classification: Class II

Recalled product

Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

Z-0593-2024

Matched recall reason

Recall reason · … Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot …

Represented date: November 30, 2023
Product type: Device
Classification: Class I

Recalled product

Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99

D-0448-2017

Matched recall reason

Recall reason · … out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time …

Represented date: December 14, 2016
Product type: Drug
Classification: Class III

Recalled product

Achieva 3.0T TX for PET Model Number (REF): 781479

Z-1841-2024

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

Achieva 1.5T Initial system Model Number (REF): 781178

Z-1838-2024

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

Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

Z-0594-2024

Matched recall reason

Recall reason · … Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot …

Represented date: November 30, 2023
Product type: Device
Classification: Class I

Recalled product

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01

D-1387-2014

Matched recall reason

Recall reason · Failed Stability Specification; out of specification result for particle size distribution during stability testing

Represented date: May 28, 2014
Product type: Drug
Classification: Class III

Recalled product

Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

Z-3126-2024

Matched product description

Product description · … It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the …

Represented date: May 27, 2024
Product type: Device
Classification: Class II

Recalled product

Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22

D-1066-2013

Matched recall reason

Recall reason · … Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

Represented date: September 13, 2013
Product type: Drug
Classification: Class II

Recalled product

SmartPath to dStream for 3.0T Model Number (REF): 782145

Z-1861-2024

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

Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE

Z-0592-2024

Matched recall reason

Recall reason · … Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot …

Represented date: November 30, 2023
Product type: Device
Classification: Class I

Recalled product

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

D-0906-2023

Matched product description

Product description · … MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

Represented date: February 09, 2023
Product type: Drug
Classification: Class II

Recalled product

BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.

D-334-2013

Matched product description

Product description · … DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count …

Represented date: December 17, 2012
Product type: Drug
Classification: Class I

Recalled product

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Z-0005-2020

Matched product description

Product description · SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an …

Represented date: September 21, 2018
Product type: Device
Classification: Class II

Recalled product

MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

Z-0735-2016

Matched recalling firm

Recalling firm · Owens & Minor Distribution, Inc.

Represented date: November 17, 2015
Product type: Device
Classification: Class II

Firms

2,180 true total · 4 on this page

Firm

Busse Hospital Disposables, Inc.

busse hospital disposables inc

Matched recall reason

Recall reason · … Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot …

Represented date: November 30, 2023
Product type: Device
Classification: Class I
Matching products: 3

Firm

Roxane Laboratories, Inc.

roxane laboratories inc

Matched recall reason

Recall reason · … out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time …

Represented date: December 14, 2016
Product type: Drug
Classification: Class III
Matching products: 1

Firm

Novartis Pharmaceuticals Corp.

novartis pharmaceuticals corp

Matched recall reason

Recall reason · Failed Stability Specification; out of specification result for particle size distribution during stability testing

Represented date: May 28, 2014
Product type: Drug
Classification: Class III
Matching products: 1

Firm

Hitachi America, Ltd., Particle Therapy Division

hitachi america ltd particle therapy division

Matched product description

Product description · … It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the …

Represented date: May 27, 2024
Product type: Device
Classification: Class II
Matching products: 3