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Recall Observatory FDA recall evidence

Current FDA corpus

Search recall evidence

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

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 76312

76312
Matched distribution pattern

Distribution pattern · Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada …

Represented date
April 04, 2016
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 85891

85891
Matched recall reason

Recall reason · A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

Represented date
March 13, 2020
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 81348

81348
Matched product description

Product description · … The images produced reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and …

Represented date
October 03, 2018
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 75028

75028
Matched recall reason

Recall reason · … It was found that product seals may become open during extreme distribution conditions and render the device unsterile.

Represented date
August 24, 2016
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 66304

66304
Matched recall reason

Recall reason · … caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).

Represented date
September 16, 2013
Product type
Device
Classification
Class II
Matching products
4

Recall event

Event 91220

91220
Matched recall reason

Recall reason · … Philips has decided to discontinue the distribution of this product.

Represented date
November 21, 2022
Product type
Device
Classification
Class II
Matching products
1

Products

24,938 true total · 15 on this page

F-3516-2017
Matched recall reason

Recall reason · The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating …

Represented date
August 02, 2017
Product type
Food
Classification
Class II
D-0380-2026
Matched recall reason

Recall reason · … recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

Represented date
February 13, 2026
Product type
Drug
Classification
Class II

Recalled product

SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Z-0236-2019
Matched product description

Product description · … The images produced reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and …

Represented date
October 03, 2018
Product type
Device
Classification
Class II
Z-0046-2014
Matched recall reason

Recall reason · … caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).

Represented date
September 16, 2013
Product type
Device
Classification
Class II
D-0650-2026
Matched recall reason

Recall reason · … Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Represented date
June 11, 2026
Product type
Drug
Classification
Class II
D-064-2013
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 · 4 on this page

aesthetics biomedical inc
Matched recall reason

Recall reason · A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

Represented date
March 13, 2020
Product type
Device
Classification
Class II
Matching products
1
ge medical systems llc
Matched product description

Product description · … The images produced reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and …

Represented date
May 01, 2026
Product type
Device
Classification
Class II
Matching products
83
integra lifesciences corp d b a integra pain management
Matched recall reason

Recall reason · … It was found that product seals may become open during extreme distribution conditions and render the device unsterile.

Represented date
August 24, 2016
Product type
Device
Classification
Class II
Matching products
7
abbott medical optics inc
Matched recall reason

Recall reason · … caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).

Represented date
February 20, 2015
Product type
Device
Classification
Class II
Matching products
9

Field note

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