State

North Dakota product recalls

20,324 recalls have nationwide distribution and so reach North Dakota. 0 additional recalls listed North Dakota specifically in their distribution scope.

About recalls in North Dakota

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect North Dakota consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

14526–14550 of 20324

SevereFDA (Devices)·Z-0883-2023·2023-01-18
Philips Trilogy 100 and 200 Ventilators Recalled for Foam Separation Risk
Silicone foam in some Philips Trilogy 100 and 200 ventilators may separate and block the air inlet, potentially reducing therapy delivery. This is an FDA Class I recall.
Product
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0884-2023·2023-01-18
Philips Garbin Ventilator Foam May Separate, Blocking Air Intake
Silicone foam in some Philips Garbin Ventilators may separate and block the air inlet, reducing therapy volume and causing alarms. Nine units are affected.
Product
Philips Garbin Ventilator, Model Number 1058180B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0908-2023·2023-01-18
Philips Fetal Spiral Electrode may break off during labor monitoring
Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.
Product
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2023·2023-01-18
Henry Shein Sterile Gloves Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Shein sterile gloves due to pinhole leaks in outer packaging that may compromise sterility. The recall affects approximately 21,755 units distributed nationwide.
Product
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2023·2023-01-18
Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk
Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.
Product
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0952-2023·2023-01-18
Medical device software bug may cause patient sample order mismatches in rare cases
A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.
Product
cobas infinity central lab, Material Number 07154003001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2023·2023-01-18
Adult Craniotome Bearings May Detach During Surgical Use
Ball bearings in the Anspach Adult Craniotome attachment may detach during removal or during surgery. Failure to follow recommended inspection intervals increases the risk of serious patient injury.
Product
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0114-2023·2023-01-18
TriMix Injection Recalled Due to Sterility Assurance Failure
Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2023·2023-01-18
IMMULITE 2000 Thyroglobulin test kits recalled for reduced analytical sensitivity
Siemens is recalling 717 IMMULITE 2000 Thyroglobulin test kits because they may not accurately measure thyroglobulin levels. Inaccurate results could affect monitoring of thyroid cancer patients.
Product
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0120-2023·2023-01-18
Compounded QuadMix injectable recalled for sterility assurance concerns
Northern VA Compounders PLLC recalled QuadMix Injectable nationwide due to lack of assurance of sterility. Patients who received this compounded medication should contact their healthcare provider immediately.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2023·2023-01-18
Craniotome Attachment Ball Bearings May Detach During Surgery
The Anspach 6.5 cm Adult Rotating Craniotome Attachment may have ball bearings that detach during surgical use or removal. The manufacturer recommends following inspection intervals to prevent serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2023·2023-01-18
Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise
Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.
Product
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2023·2023-01-18
Tacy Medical Syringe Convenience Packs Recalled Due to Potential Sterility Loss
Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 U.S. states.
Product
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2023·2023-01-18
Source Administration Set medical device recalled for contamination
The FDA has recalled 2,840 units of the Source Administration Set, a medical device used for PET imaging, due to contamination with black specks on needles.
Product
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2023·2023-01-18
Sterile EVA Medical Bags Recalled Due to Pinhole Leak Risk
Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 units were distributed nationwide.
Product
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0922-2023·2023-01-18
Surgical Craniotome Attachment Ball Bearings Have Detached During Surgery
The Anspach 7.5 cm Large Rotating Craniotome Attachment ball bearings have come out during surgery or device removal. Failure to follow proper inspection intervals may result in serious patient injury.
Product
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2023·2023-01-18
Stradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach
Stradis Healthcare is recalling 600 units of Tacy Medical sterile port access trays due to potential pinhole leaks in the outer packaging that could compromise sterility.
Product
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0920-2023·2023-01-18
Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery
Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.
Product
7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0109-2023·2023-01-18
Prostaglandin E1 Injection Recall Due to Sterility Assurance Failure
Northern VA Compounders has recalled Prostaglandin E1 Injection Solution due to lack of assurance of sterility in the compounding process. The affected lot was distributed nationwide.
Product
Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2023·2023-01-18
Compounded TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling 750 vials of TriMix Original injectable nationwide due to lack of assurance of sterility. Patients should discontinue use and consult their healthcare provider.
Product
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2023·2023-01-18
Anspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
The Anspach Adult Rotating Craniotome Attachment (CRANI-A-R) may have ball bearings that detach during surgical use. The FDA recommends users follow inspection intervals to prevent potential serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0253-2023·2023-01-18
Sanders Dark Chocolate Maple Sea Salt Caramel Recalled for Foreign Material
Sanders Candy LLC is recalling Sanders Dark Chocolate Maple Sea Salt Caramel due to brush bristles found in the product. Consumers should not consume affected units.
Product
Sanders Dark Chocolate Maple Sea Salt Caramel: No UPC 6oz. foil bag
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0943-2023·2023-01-18
McCormick Medical Distribution PORT TRAY recalled for potential sterility breaches
Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.
Product
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0917-2023·2023-01-18
Craniotome Attachment Ball Bearings May Separate During Surgery
The FDA is recalling a surgical craniotome attachment after ball bearings can separate from the device. Failure to follow inspection protocols may result in serious patient injury during neurosurgery.
Product
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2023·2023-01-18
HCT 500mL Sterile Medical Bags Recalled for Potential Pinhole Leaks
Stradis Healthcare is recalling HCT 500mL sterile medical bags due to potential pinhole leaks near the seal that could compromise sterility. The recall affects 644 units distributed across nine U.S. states.
Product
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide