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 · 7 on this page

Recall event

Event 89527

89527

Matched recall reason

Recall reason · … The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

Represented date: January 31, 2022
Product type: Device
Classification: Class I
Matching products: 1

Recall event

Event 90505

90505

Matched recall reason

Recall reason · … Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

Represented date: June 10, 2022
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 90381

90381

Matched recall reason

Recall reason · Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers …

Represented date: June 15, 2022
Product type: Device
Classification: Class I
Matching products: 1

Recall event

Event 66316

66316

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
Matching products: 2

Recall event

Event 69560

69560

Matched product description

Product description · … Recording and distribution of images and videos and interaction with medical and non-medical devices.

Represented date: August 21, 2014
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 63916

63916

Matched product description

Product description · … DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count …

Represented date: December 17, 2012
Product type: Drug
Classification: Class I
Matching products: 2

Recall event

Event 63707

63707

Matched recall reason

Recall reason · … These lots are being recalled due to the failure to meet the particle size distribution specification.

Represented date: October 24, 2012
Product type: Drug
Classification: Class III
Matching products: 2

Products

24,938 true total · 10 on this page

Recalled product

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only

Z-1918-2023

Matched product description

Product description · Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only

Represented date: April 22, 2023
Product type: Device
Classification: Class II

Recalled product

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

Z-0719-2022

Matched recall reason

Recall reason · … The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

Represented date: January 31, 2022
Product type: Device
Classification: Class I

Recalled product

RayStation 11B

Z-1299-2022

Matched recall reason

Recall reason · … Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

Represented date: June 10, 2022
Product type: Device
Classification: Class II

Recalled product

SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT

Z-1401-2022

Matched recall reason

Recall reason · Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers …

Represented date: June 15, 2022
Product type: Device
Classification: Class I

Recalled product

Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9

D-1661-2012

Matched recall reason

Recall reason · Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

Represented date: June 14, 2007
Product type: Drug
Classification: Class II

Recalled product

Ifosfamide Injection 1g/20mL, 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 0069-4495-22

D-1065-2013

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

TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.

Z-0993-2015

Matched product description

Product description · … Recording and distribution of images and videos and interaction with medical and non-medical devices.

Represented date: August 21, 2014
Product type: Device
Classification: Class II

Recalled product

UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,

D-0783-2016

Matched product description

Product description · UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,

Represented date: September 16, 2015
Product type: Drug
Classification: Class III

Recalled product

BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536

D-335-2013

Matched product description

Product description · … DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count …

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

Recalled product

Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.

D-065-2013

Matched recall reason

Recall reason · … These lots are being recalled due to the failure to meet the particle size distribution specification.

Represented date: October 24, 2012
Product type: Drug
Classification: Class III

Firms

2,180 true total · 8 on this page

Firm

SD Biosensor, Inc.

sd biosensor inc

Matched recall reason

Recall reason · … The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

Represented date: January 31, 2022
Product type: Device
Classification: Class I
Matching products: 1

Firm

RAYSEARCH LABORATORIES AB

raysearch laboratories ab

Matched recall reason

Recall reason · … Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

Represented date: May 20, 2026
Product type: Device
Classification: Class II
Matching products: 79

Firm

North American Diagnostics

north american diagnostics

Matched recall reason

Recall reason · Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers …

Represented date: June 15, 2022
Product type: Device
Classification: Class I
Matching products: 1

Firm

AmeriSource Bergen

amerisource bergen

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
Matching products: 2

Firm

Maquet Medical Systems USA

maquet medical systems usa

Matched product description

Product description · … Recording and distribution of images and videos and interaction with medical and non-medical devices.

Represented date: April 15, 2024
Product type: Device
Classification: Class II
Matching products: 38

FDA name variants: Maquet Medical Systems USA · Maquet Medical Systems, Usa

Firm

Performance Plus Marketing, Inc.

performance plus marketing inc

Matched product description

Product description · … DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count …

Represented date: December 17, 2012
Product type: Drug
Classification: Class I
Matching products: 2

Firm

GlaxoSmithKline, LLC.

glaxosmithkline llc

Matched recall reason

Recall reason · … These lots are being recalled due to the failure to meet the particle size distribution specification.

Represented date: October 17, 2013
Product type: Drug
Classification: Class III
Matching products: 3

FDA name variants: GlaxoSmithKline, LLC. · GlaxoSmithKline, LLC · GlaxoSmithKline LLC

Firm

Soft Computer Consultants, Inc.

soft computer consultants inc

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: March 31, 2021
Product type: Device
Classification: Class II
Matching products: 3