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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 · 7 on this page

Recall event

Event 83509

83509
Matched product description

Product description · SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an …

Represented date
September 21, 2018
Product type
Device
Classification
Class II
Matching products
8

Recall event

Event 95607

95607
Matched recall reason

Recall reason · … An intended use on the label has not been reviewed and approved by FDA for distribution in the …

Represented date
October 21, 2024
Product type
Device
Classification
Class II
Matching products
1

Recall event

Event 74891

74891
Matched recall reason

Recall reason · Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.

Represented date
August 05, 2016
Product type
Device
Classification
Class II
Matching products
2

Recall event

Event 84991

84991
Matched product description

Product description · … No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 …

Represented date
February 10, 2020
Product type
Device
Classification
Class II
Matching products
2

Recall event

Event 72910

72910
Matched recalling firm

Recalling firm · Owens & Minor Distribution, Inc.

Represented date
November 17, 2015
Product type
Device
Classification
Class II
Matching products
3

Recall event

Event 83190

83190
Matched product description

Product description · … Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.

Represented date
June 21, 2019
Product type
Drug
Classification
Class II
Matching products
1

Recall event

Event 92301

92301
Matched product description

Product description · Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only

Represented date
April 22, 2023
Product type
Device
Classification
Class II
Matching products
13

Products

24,938 true total · 11 on this page

Z-0006-2020
Matched product description

Product description · SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an …

Represented date
September 21, 2018
Product type
Device
Classification
Class II
Z-2762-2016
Matched recall reason

Recall reason · Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.

Represented date
August 05, 2016
Product type
Device
Classification
Class II
Z-1447-2020
Matched product description

Product description · … No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 …

Represented date
February 10, 2020
Product type
Device
Classification
Class II
D-1503-2019
Matched product description

Product description · … Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.

Represented date
June 21, 2019
Product type
Drug
Classification
Class II

Firms

2,180 true total · 7 on this page

praxair inc
Matched product description

Product description · UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.

Represented date
September 16, 2015
Product type
Drug
Classification
Class III
Matching products
3
the metrix company
Matched product description

Product description · SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an …

Represented date
October 09, 2024
Product type
Device
Classification
Class II
Matching products
24
karl storz endoscopy
Matched recall reason

Recall reason · … An intended use on the label has not been reviewed and approved by FDA for distribution in the …

Represented date
December 19, 2024
Product type
Device
Classification
Class II
Matching products
45
riverpoint medical llc
Matched recall reason

Recall reason · Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.

Represented date
October 25, 2023
Product type
Device
Classification
Class II
Matching products
44
covidien llc
Matched product description

Product description · … No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 …

Represented date
April 23, 2026
Product type
Device
Classification
Class II
Matching products
235

FDA name variants: Covidien LLC · Covidien Llc · COVIDIEN LLC

pharma natural inc
Matched product description

Product description · … Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.

Represented date
June 21, 2019
Product type
Drug
Classification
Class II
Matching products
1
merit medical systems inc
Matched product description

Product description · Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only

Represented date
May 08, 2026
Product type
Device
Classification
Class II
Matching products
106

FDA name variants: Merit Medical Systems, Inc. · Merit Medical Systems, Inc

Field note

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