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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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 · 8 on this page

Recall event

Event 86655

86655

Matched code information

Code information · … BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US …

Represented date: October 05, 2020
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 76309

76309

Matched distribution pattern

Distribution pattern · Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as …

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

Recall event

Event 83518

83518

Matched recall reason

Recall reason · Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.

Represented date: August 08, 2018
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 72288

72288

Matched code information

Code information · … CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires …

Represented date: September 03, 2015
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 70383

70383

Matched product description

Product description · … Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Represented date: November 30, 2012
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 73469

73469

Matched code information

Code information · All distribution dates :3/2003-4/2016

Represented date: December 23, 2015
Product type: Device
Classification: Class II
Matching products: 5

Recall event

Event 83187

83187

Matched product description

Product description · … The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system …

Represented date: June 03, 2019
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 88088

88088

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida …

Represented date: June 10, 2021
Product type: Device
Classification: Class II
Matching products: 2

Products

24,938 true total · 12 on this page

Recalled product

BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

Z-0562-2021

Matched code information

Code information · … BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US …

Represented date: October 05, 2020
Product type: Device
Classification: Class II

Recalled product

Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)

F-3531-2017

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

Recalled product

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

Z-1681-2017

Matched distribution pattern

Distribution pattern · Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as …

Represented date: April 04, 2016
Product type: Device
Classification: Class II

Recalled product

ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB

D-0646-2026

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

Recalled product

ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Z-0018-2020

Matched recall reason

Recall reason · Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.

Represented date: August 08, 2018
Product type: Device
Classification: Class II

Recalled product

Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.

Z-0341-2016

Matched code information

Code information · … CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires …

Represented date: September 03, 2015
Product type: Device
Classification: Class II

Recalled product

Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Z-1146-2015

Matched product description

Product description · … Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Represented date: November 30, 2012
Product type: Device
Classification: Class II

Recalled product

Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148

Z-1843-2024

Matched recall reason

Recall reason · The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may …

Represented date: May 03, 2024
Product type: Device
Classification: Class II

Recalled product

Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

Z-1861-2016

Matched code information

Code information · All distribution dates :3/2003-4/2016

Represented date: December 23, 2015
Product type: Device
Classification: Class II

Recalled product

Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

Z-1929-2019

Matched product description

Product description · … The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system …

Represented date: June 03, 2019
Product type: Device
Classification: Class II

Recalled product

Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.

Z-2066-2021

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida …

Represented date: June 10, 2021
Product type: Device
Classification: Class II

Recalled product

Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

Z-1864-2016

Matched code information

Code information · All distribution dates :3/2003-4/2016

Represented date: December 23, 2015
Product type: Device
Classification: Class II

Firms

2,180 true total · 5 on this page

Firm

Becton, Dickinson and Company, BD Biosciences

becton dickinson and company bd biosciences

Matched code information

Code information · … BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US …

Represented date: October 25, 2023
Product type: Device
Classification: Class II
Matching products: 15

Firm

Implant Direct Sybron Manufacturing, LLC

implant direct sybron manufacturing llc

Matched recall reason

Recall reason · Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.

Represented date: May 01, 2025
Product type: Device
Classification: Class II
Matching products: 16

FDA name variants: Implant Direct Sybron Manufacturing, LLC · Implant Direct Sybron Manufacturing LLC

Firm

Leica Microsystems, Inc.

leica microsystems inc

Matched code information

Code information · … CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires …

Represented date: August 26, 2022
Product type: Device
Classification: Class II
Matching products: 18

Firm

Biomet Spine, LLC

biomet spine llc

Matched product description

Product description · … Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Represented date: February 12, 2016
Product type: Device
Classification: Class II
Matching products: 8

FDA name variants: Biomet Spine, LLC · Biomet Spine LLC.

Firm

Mercedes Medical, Inc.

mercedes medical inc

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida …

Represented date: June 10, 2021
Product type: Device
Classification: Class II
Matching products: 2