State

North Dakota product recalls

72,986 recalls have nationwide distribution and so reach North Dakota. 2,921 additional recalls listed North Dakota specifically in their distribution scope.

What the numbers show

Total: 2,921
Critical: 265
Severe: 727
Most recent: 2026-09-02

Of the 2,921 recalls naming North Dakota we have scored against our rubric, 265 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 727 (25%) are Severe.

Which agencies issued them

These figures cover only the 2,921 recalls whose distribution notice names North Dakota specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7251–7275 of 75907

HighFDA (Devices)·Z-1382-2025·2025-03-26
Microstream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1357-2025·2025-03-26
General Laparoscopic Pack Recall Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Product
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2025·2025-03-26
DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2025·2025-03-26
Hip Prosthesis Pack Recalled Due to Sterilization Assurance Concerns
American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.
Product
TOTAL HIP PACK , Model No SMTH06O SMTH06P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1360-2025·2025-03-26
Lumbar Spine Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.
Product
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1345-2025·2025-03-26
FDA Recalls URO Robotic Pack Surgical Kit Due to Sterilization Concerns
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
Product
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2025·2025-03-26
Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2025·2025-03-26
Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube
Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2025·2025-03-26
CO2 Sampling Lines May Fail to Disconnect During Neonatal Care
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1344-2025·2025-03-26
Labor and Delivery System Recalled for Sterilization Assurance Issue
American Contract Systems is recalling 1,836 Labor and Delivery PPS kits due to inability to confirm sterilization requirements were met. The affected units may lose functionality, potentially delaying patient treatment.
Product
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1393-2025·2025-03-26
Medline C-Section Procedure Kits Recalled for Defective Syringes
Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1370-2025·2025-03-26
Surgical drapes recalled due to potential sterility breach in packaging
Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.
Product
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1363-2025·2025-03-26
Medline Proxima sterile surgical drapes recalled due to potential packaging breach
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
Product
Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0290-2025·2025-03-26
Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency
Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1356-2025·2025-03-26
AV Fistula Kit Recall Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.
Product
AV FISTULA , Model No UTAV77T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1375-2025·2025-03-26
BD Pyxis Medication Dispensing Systems Software Sync Error Recall
BD Pyxis medication dispensing systems may disconnect from their server due to a software error, preventing them from receiving medication updates. This could lead to incorrect medication administration or delayed access to medications.
Product
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1361-2025·2025-03-26
Thoracic Packs Recalled for Unconfirmed Sterilization Assurance by Manufacturer
American Contract Systems recalls 40 kits of Thoracic Packs (Models UTTC82Y and UTTC82AA-01) due to inability to confirm sterilization assurance was met. Unsterilized packs may lose functionality and delay emergency treatment.
Product
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2025·2025-03-26
Medical Device Software May Merge Patient Records Without Notification
Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.
Product
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2025·2025-03-26
CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure
The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.
Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.
Product
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2025·2025-03-26
Laceration Tray Kits Recalled Due to Sterilization Assurance Failure
American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.
Product
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1364-2025·2025-03-26
Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging
Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.
Product
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1352-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
Product
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0287-2025·2025-03-26
FDA Recalls Prasugrel Tablets for Failed Dissolution Specifications
Golden State Medical Supply Inc. is recalling 2,601 bottles of Prasugrel 5 mg tablets due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug absorption.
Product
PRASUGREL — PRASUGREL (PRASUGREL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2025·2025-03-26
Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
Product
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Category
Medical Device
Distribution
Distributed nationwide