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Search recall evidence

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 76228

76228

Matched product description

Product description · … health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the …

Represented date: February 20, 2017
Product type: Device
Classification: Class II
Matching products: 4

Recall event

Event 61802

61802

Matched recall reason

Recall reason · … products are being recalled because there is potential that vials with low fill volume were released into distribution.

Represented date: May 01, 2012
Product type: Drug
Classification: Class II
Matching products: 2

Recall event

Event 62577

62577

Matched recall reason

Recall reason · The impacted product was not intended for commercial distribution to end users.

Represented date: December 31, 2010
Product type: Device
Classification: Class III
Matching products: 1

Recall event

Event 77830

77830

Matched product description

Product description · … These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other …

Represented date: June 26, 2017
Product type: Device
Classification: Class II
Matching products: 2

Recall event

Event 78182

78182

Matched recall reason

Recall reason · Distribution of unapproved devices with incorrect air compression level setup

Represented date: January 13, 2017
Product type: Device
Classification: Class II
Matching products: 2

Recall event

Event 80464

80464

Matched product description

Product description · … The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance …

Represented date: June 18, 2018
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 82033

82033

Matched product description

Product description · … The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are …

Represented date: December 19, 2018
Product type: Device
Classification: Class II
Matching products: 1

Products

24,938 true total · 12 on this page

Recalled product

Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.

Z-1425-2017

Matched product description

Product description · … health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the …

Represented date: February 20, 2017
Product type: Device
Classification: Class II

Recalled product

Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.

Z-1423-2017

Matched product description

Product description · … health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the …

Represented date: February 20, 2017
Product type: Device
Classification: Class II

Recalled product

Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8.

D-1376-2012

Matched recall reason

Recall reason · … products are being recalled because there is potential that vials with low fill volume were released into distribution.

Represented date: May 01, 2012
Product type: Drug
Classification: Class II

Recalled product

ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Z-2425-2012

Matched recall reason

Recall reason · The impacted product was not intended for commercial distribution to end users.

Represented date: December 31, 2010
Product type: Device
Classification: Class III

Recalled product

MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483

Z-1857-2024

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 PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.

D-0644-2026

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

Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.

Z-1424-2017

Matched product description

Product description · … health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the …

Represented date: February 20, 2017
Product type: Device
Classification: Class II

Recalled product

Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1.

D-1377-2012

Matched recall reason

Recall reason · … products are being recalled because there is potential that vials with low fill volume were released into distribution.

Represented date: May 01, 2012
Product type: Drug
Classification: Class II

Recalled product

Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 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, or any other test that aids in diagnosing an abnormality

Z-3113-2017

Matched product description

Product description · … These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other …

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

Recalled product

Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

Z-0205-2018

Matched recall reason

Recall reason · Distribution of unapproved devices with incorrect air compression level setup

Represented date: January 13, 2017
Product type: Device
Classification: Class II

Recalled product

Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Z-2479-2018

Matched product description

Product description · … The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance …

Represented date: June 18, 2018
Product type: Device
Classification: Class II

Recalled product

Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging).

Z-0823-2019

Matched product description

Product description · … The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are …

Represented date: December 19, 2018
Product type: Device
Classification: Class II

Firms

2,180 true total · 6 on this page

Firm

Siemens Medical Solutions USA, Inc

siemens medical solutions usa inc

Matched product description

Product description · … health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the …

Represented date: June 08, 2026
Product type: Device
Classification: Class II
Matching products: 513

FDA name variants: Siemens Medical Solutions USA, Inc · Siemens Medical Solutions USA, Inc. · Siemens Medical Solutions USA Inc.

Firm

Kimberly-Clark Corporation

kimberly clark corporation

Matched recall reason

Recall reason · The impacted product was not intended for commercial distribution to end users.

Represented date: December 11, 2018
Product type: Device
Classification: Class III
Matching products: 14

Firm

Ben Venue Laboratories Inc

ben venue laboratories inc

Matched recall reason

Recall reason · … products are being recalled because there is potential that vials with low fill volume were released into distribution.

Represented date: May 01, 2012
Product type: Drug
Classification: Class II
Matching products: 2

Firm

Beckman Coulter Inc.

beckman coulter inc

Matched product description

Product description · … These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other …

Represented date: March 16, 2026
Product type: Device
Classification: Class II
Matching products: 201

FDA name variants: Beckman Coulter Inc. · Beckman Coulter, Inc. · Beckman Coulter Inc

Firm

Won Industry Co.

won industry co

Matched recall reason

Recall reason · Distribution of unapproved devices with incorrect air compression level setup

Represented date: January 13, 2017
Product type: Device
Classification: Class II
Matching products: 2

Firm

Hitachi Medical Systems America Inc

hitachi medical systems america inc

Matched product description

Product description · … The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance …

Represented date: March 01, 2021
Product type: Device
Classification: Class II
Matching products: 11