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Recall Observatory FDA recall evidence

Current FDA corpus

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

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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 73555

73555
Matched product description

Product description · … The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic …

Represented date
March 01, 2016
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 81861

81861
Matched distribution pattern

Distribution pattern · Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS …

Represented date
August 28, 2018
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 78289

78289
Matched distribution pattern

Distribution pattern · Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.

Represented date
October 10, 2017
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 68654

68654
Matched recall reason

Recall reason · … Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached …

Represented date
July 01, 2014
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 83633

83633
Matched distribution pattern

Distribution pattern · Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and …

Represented date
October 16, 2018
Product type
Device
Classification
Class II
Matching products
9

Recall event

Event 76654

76654
Matched distribution pattern

Distribution pattern · USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.

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

Products

24,938 true total · 15 on this page

Recalled product

SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer 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 by the SIGNA Pioneer 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-1347-2016
Matched product description

Product description · … The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic …

Represented date
March 01, 2016
Product type
Device
Classification
Class II
Z-1296-2019
Matched distribution pattern

Distribution pattern · Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS …

Represented date
August 28, 2018
Product type
Device
Classification
Class II
Z-0098-2018
Matched distribution pattern

Distribution pattern · Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.

Represented date
October 10, 2017
Product type
Device
Classification
Class II
Z-2215-2014
Matched recall reason

Recall reason · … Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached …

Represented date
July 01, 2014
Product type
Device
Classification
Class II
Z-1333-2019
Matched distribution pattern

Distribution pattern · Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium …

Represented date
February 02, 2018
Product type
Device
Classification
Class II

Firms

2,180 true total · 4 on this page

shippert medical technologies
Matched distribution pattern

Distribution pattern · Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium …

Represented date
February 02, 2018
Product type
Device
Classification
Class II
Matching products
14
abbott laboratories inc
Matched distribution pattern

Distribution pattern · Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS …

Represented date
February 03, 2022
Product type
Device
Classification
Class II
Matching products
28

FDA name variants: Abbott Laboratories, Inc · Abbott Laboratories, Inc.

zimmer inc
Matched recall reason

Recall reason · … Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached …

Represented date
May 20, 2026
Product type
Device
Classification
Class II
Matching products
386

FDA name variants: Zimmer, Inc. · Zimmer Inc.

argon medical devices inc
Matched distribution pattern

Distribution pattern · Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and …

Represented date
September 12, 2025
Product type
Device
Classification
Class II
Matching products
27

Field note

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