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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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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 · 6 on this page

Recall event

Event 83303

83303

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution, including Puerto Rico. There was government and foreign distribution and no military distribution …

Represented date: May 02, 2019
Product type: Device
Classification: Class II
Matching products: 6

Recall event

Event 85016

85016

Matched code information

Code information · Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2 …

Represented date: February 11, 2020
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 88219

88219

Matched code information

Code information · Product Code T5C8500 (distribution in Japan only)

Represented date: June 30, 2021
Product type: Device
Classification: Class II
Matching products: 2

Recall event

Event 63430

63430

Matched recall reason

Recall reason · … is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.

Represented date: October 05, 2012
Product type: Device
Classification: Class II
Matching products: 1

Recall event

Event 66372

66372

Matched code information

Code information · ***** US DISTRIBUTION ***** *** 1) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 1) List Number: 19732-04 …

Represented date: September 09, 2013
Product type: Device
Classification: Class II
Matching products: 5

Recall event

Event 66711

66711

Matched product description

Product description · … By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 …

Represented date: November 01, 2013
Product type: Drug
Classification: Class II
Matching products: 2

Products

24,938 true total · 13 on this page

Recalled product

Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

Z-1592-2024

Matched code information

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

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

Recalled product

smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.

Z-0075-2019

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

Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

Z-2067-2021

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

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Z-2212-2019

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution, including Puerto Rico. There was government and foreign distribution and no military distribution …

Represented date: May 02, 2019
Product type: Device
Classification: Class II

Recalled product

Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.

Z-1559-2020

Matched code information

Code information · Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2 …

Represented date: February 11, 2020
Product type: Device
Classification: Class II

Recalled product

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Z-2211-2019

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution, including Puerto Rico. There was government and foreign distribution and no military distribution …

Represented date: May 02, 2019
Product type: Device
Classification: Class II

Recalled product

Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.

Z-0090-2024

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

smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.

Z-0074-2019

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

Kaguya Automated Peritoneal Dialysis System

Z-2174-2021

Matched code information

Code information · Product Code T5C8500 (distribution in Japan only)

Represented date: June 30, 2021
Product type: Device
Classification: Class II

Recalled product

Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

Z-0206-2013

Matched recall reason

Recall reason · … is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.

Represented date: October 05, 2012
Product type: Device
Classification: Class II

Recalled product

* 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; * 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

Z-2061-2016

Matched code information

Code information · ***** US DISTRIBUTION ***** *** 1) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 1) List Number: 19732-04 …

Represented date: September 09, 2013
Product type: Device
Classification: Class II

Recalled product

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Z-2214-2019

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution, including Puerto Rico. There was government and foreign distribution and no military distribution …

Represented date: May 02, 2019
Product type: Device
Classification: Class II

Recalled product

Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2

D-005-2014

Matched product description

Product description · … By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 …

Represented date: November 01, 2013
Product type: Drug
Classification: Class II

Firms

2,180 true total · 6 on this page

Firm

ACTIM OY

actim oy

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

Firm

Bard Peripheral Vascular Inc

bard peripheral vascular inc

Matched distribution pattern

Distribution pattern · Worldwide distribution - US Nationwidedistribution, including Puerto Rico. There was government and foreign distribution and no military distribution …

Represented date: December 12, 2025
Product type: Device
Classification: Class II
Matching products: 76

FDA name variants: Bard Peripheral Vascular Inc · BARD PERIPHERAL VASCULAR, INC

Firm

Intellijoint Surgical, Inc.

intellijoint surgical inc

Matched code information

Code information · Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2 …

Represented date: February 11, 2020
Product type: Device
Classification: Class II
Matching products: 1

Firm

Hospira Inc.

hospira inc

Matched code information

Code information · ***** US DISTRIBUTION ***** *** 1) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 1) List Number: 19732-04 …

Represented date: October 06, 2014
Product type: Device
Classification: Class II
Matching products: 86

FDA name variants: Hospira Inc. · Hospira, Inc.

Firm

L. Perrigo Co.

l perrigo co

Matched product description

Product description · … By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 …

Represented date: November 01, 2013
Product type: Drug
Classification: Class II
Matching products: 2

Firm

Thoratec Switzerland GMBH

thoratec switzerland gmbh

Matched distribution pattern

Distribution pattern · Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile …

Represented date: May 22, 2024
Product type: Device
Classification: Class I
Matching products: 2