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 93793

93793

Matched recall reason

Recall reason · … Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a …

Represented date: December 29, 2023
Product type: Device
Classification: Class II
Matching products: 2

Recall event

Event 89455

89455

Matched recall reason

Recall reason · … test kit is different from the US test kit and is NOT authorized for distribution in the US.

Represented date: December 01, 2021
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 87569

87569

Matched product description

Product description · … 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

Represented date: March 09, 2021
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 89464

89464

Matched product description

Product description · … DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270

Represented date: January 24, 2022
Product type: Drug
Classification: Class II
Matching products: 1

Recall event

Event 89539

89539

Matched recall reason

Recall reason · … Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Represented date: January 13, 2022
Product type: Device
Classification: Class I
Matching products: 3

Recall event

Event 88927

88927

Matched recall reason

Recall reason · … Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

Represented date: October 22, 2021
Product type: Drug
Classification: Class II
Matching products: 1

Products

24,938 true total · 13 on this page

Recalled product

Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR 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-3125-2024

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

Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V 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-3127-2024

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

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (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-0004-2020

Matched product description

Product description · SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an …

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

Recalled product

Blue Planet, 10311 9 Grain Granola, NET WEIGHT 900 lbs (bulk product)

F-1207-2013

Matched recall reason

Recall reason · Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and …

Represented date: February 19, 2013
Product type: Food
Classification: Class II

Recalled product

MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"

Z-0867-2024

Matched recall reason

Recall reason · … Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a …

Represented date: December 29, 2023
Product type: Device
Classification: Class II

Recalled product

Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.

Z-0558-2022

Matched recall reason

Recall reason · … test kit is different from the US test kit and is NOT authorized for distribution in the US.

Represented date: December 01, 2021
Product type: Device
Classification: Class II

Recalled product

A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

Z-1368-2021

Matched product description

Product description · … 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

Represented date: March 09, 2021
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-0734-2016

Matched recalling firm

Recalling firm · Owens & Minor Distribution, Inc.

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

Recalled product

DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270

D-0472-2022

Matched product description

Product description · … DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270

Represented date: January 24, 2022
Product type: Drug
Classification: Class II

Recalled product

COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

Z-0718-2022

Matched recall reason

Recall reason · … Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Represented date: January 13, 2022
Product type: Device
Classification: Class I

Recalled product

LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

Z-0716-2022

Matched recall reason

Recall reason · … Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Represented date: January 13, 2022
Product type: Device
Classification: Class I

Recalled product

MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";

Z-0866-2024

Matched recall reason

Recall reason · … Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a …

Represented date: December 29, 2023
Product type: Device
Classification: Class II

Recalled product

Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.

D-0361-2022

Matched recall reason

Recall reason · … Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

Represented date: October 22, 2021
Product type: Drug
Classification: Class II

Firms

2,180 true total · 6 on this page

Firm

Aesculap, Inc.

aesculap inc

Matched recall reason

Recall reason · … Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a …

Represented date: January 15, 2026
Product type: Device
Classification: Class II
Matching products: 29

FDA name variants: Aesculap, Inc. · Aesculap Inc

Firm

CELLTRION USA INC

celltrion usa inc

Matched recall reason

Recall reason · … test kit is different from the US test kit and is NOT authorized for distribution in the US.

Represented date: April 01, 2022
Product type: Device
Classification: Class II
Matching products: 2

Firm

Medtronic Neuromodulation

medtronic neuromodulation

Matched product description

Product description · … 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

Represented date: May 13, 2026
Product type: Device
Classification: Class II
Matching products: 60

Firm

Ultra Seal Corporation

ultra seal corporation

Matched product description

Product description · … DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270

Represented date: January 24, 2022
Product type: Drug
Classification: Class II
Matching products: 1

Firm

Lusys Laboratories, Inc.

lusys laboratories inc

Matched recall reason

Recall reason · … Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Represented date: January 13, 2022
Product type: Device
Classification: Class I
Matching products: 3

Firm

SUN PHARMACEUTICAL INDUSTRIES INC

sun pharmaceutical industries inc

Matched recall reason

Recall reason · … Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

Represented date: October 22, 2021
Product type: Drug
Classification: Class II
Matching products: 1

FDA name variants: SUN PHARMACEUTICAL INDUSTRIES INC · Sun Pharmaceutical Industries, Inc. · Sun Pharmaceutical Industries Inc.