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 · 7 on this page

Recall event

Event 83583

83583

Matched distribution pattern

Distribution pattern · Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.

Represented date: August 24, 2018
Product type: Device
Classification: Class II
Matching products: 2

Recall event

Event 91698

91698

Matched product description

Product description · … PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC …

Represented date: January 30, 2023
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 90587

90587

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There …

Represented date: June 24, 2022
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 69094

69094

Matched recall reason

Recall reason · … lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the …

Represented date: August 20, 2014
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 80635

80635

Matched distribution pattern

Distribution pattern · Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ …

Represented date: July 06, 2018
Product type: Device
Classification: Class III
Matching products: 5

Recall event

Event 94968

94968

Matched recall reason

Recall reason · Products in distribution were found by FDA to be to be substantially different from the current cleared 510 …

Represented date: May 09, 2024
Product type: Device
Classification: Class II
Matching products: 6

Recall event

Event 93845

93845

Matched code information

Code information · UDI/DI 06430030990608, All serial numbers in distribution

Represented date: November 23, 2023
Product type: Device
Classification: Class II
Matching products: 1

Products

24,938 true total · 14 on this page

Recalled product

Fetal Spiral Electrode, Model No. 9898 031 37631

Z-1250-2019

Matched code information

Code information · All products currently in distribution.

Represented date: January 25, 2019
Product type: Device
Classification: Class II

Recalled product

Beckman Coulter Lipase, REF OSR6130 and OSR6230.

Z-0210-2020

Matched distribution pattern

Distribution pattern · Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.

Represented date: August 24, 2018
Product type: Device
Classification: Class II

Recalled product

DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).

Z-1206-2023

Matched product description

Product description · … PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC …

Represented date: January 30, 2023
Product type: Device
Classification: Class II

Recalled product

SIGNA Premier magnetic resonance scanner, model 5748519.

Z-1430-2022

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There …

Represented date: June 24, 2022
Product type: Device
Classification: Class II

Recalled product

Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.

Z-0211-2020

Matched distribution pattern

Distribution pattern · Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.

Represented date: August 24, 2018
Product type: Device
Classification: Class II

Recalled product

VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0007-2015

Matched recall reason

Recall reason · … lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the …

Represented date: August 20, 2014
Product type: Device
Classification: Class II

Recalled product

smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

Z-0072-2019

Matched distribution pattern

Distribution pattern · Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ …

Represented date: July 06, 2018
Product type: Device
Classification: Class III

Recalled product

Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

Z-0085-2024

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL …

Represented date: August 16, 2023
Product type: Device
Classification: Class II

Recalled product

Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality

Z-3114-2017

Matched product description

Product description · … These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that …

Represented date: June 26, 2017
Product type: Device
Classification: Class II

Recalled product

Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474

Z-1856-2024

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

BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

D-0649-2026

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

smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

Z-0071-2019

Matched distribution pattern

Distribution pattern · Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ …

Represented date: July 06, 2018
Product type: Device
Classification: Class III

Recalled product

smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

Z-0073-2019

Matched distribution pattern

Distribution pattern · Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ …

Represented date: July 06, 2018
Product type: Device
Classification: Class III

Recalled product

Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;

Z-3077-2024

Matched recall reason

Recall reason · Products in distribution were found by FDA to be to be substantially different from the current cleared 510 …

Represented date: May 09, 2024
Product type: Device
Classification: Class II

Firms

2,180 true total · 4 on this page

Firm

Carestream Health Inc.

carestream health inc

Matched product description

Product description · … PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC …

Represented date: October 02, 2023
Product type: Device
Classification: Class II
Matching products: 27

FDA name variants: Carestream Health Inc. · Carestream Health, Inc. · Carestream Health Inc

Firm

Ortho-Clinical Diagnostics

ortho clinical diagnostics

Matched recall reason

Recall reason · … lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the …

Represented date: February 27, 2024
Product type: Device
Classification: Class II
Matching products: 195

FDA name variants: Ortho-Clinical Diagnostics · Ortho Clinical Diagnostics · ORTHO-CLINICAL DIAGNOSTICS

Firm

Smiths Medical ASD Inc.

smiths medical asd inc

Matched distribution pattern

Distribution pattern · Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ …

Represented date: April 10, 2025
Product type: Device
Classification: Class III
Matching products: 118

FDA name variants: Smiths Medical ASD Inc. · Smiths Medical ASD, Inc. · Smiths Medical Asd Inc

Firm

Sol-Millennium Medical Inc.

sol millennium medical inc

Matched recall reason

Recall reason · Products in distribution were found by FDA to be to be substantially different from the current cleared 510 …

Represented date: May 09, 2024
Product type: Device
Classification: Class II
Matching products: 6