State

Montana product recalls

20,364 recalls have nationwide distribution and so reach Montana. 0 additional recalls listed Montana specifically in their distribution scope.

About recalls in Montana

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 Montana 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.

13501–13525 of 20364

HighFDA (Devices)·Z-1432-2023·2023-05-03
Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk
ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2023·2023-05-03
Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect
Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.
Product
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1467-2023·2023-05-03
Stryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions
Wright Medical Technology is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants due to incorrect dorsiflexion descriptions laser marked on 50 units distributed nationwide.
Product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0569-2023·2023-05-03
Fyremadel Ganirelix Acetate Injection Recalled for Glass Contamination
Sun Pharmaceutical is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection due to glass contamination found in a unit from lot HAD1190A. The recall affects units distributed nationwide with expiration 02/2024.
Product
FYREMADEL — FYREMADEL (GANIRELIX ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1464-2023·2023-05-03
VersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect
Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.
Product
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1461-2023·2023-05-03
GEM NEUROTUBE Nerve Repair Mesh Recalled for Brittleness and Potential Crumbling
Baxter Healthcare's GEM NEUROTUBE absorbable mesh tube, used for peripheral nerve repair, is recalled because the product is brittle and may crumble when handled or removed from packaging. The recall affects 169 units distributed worldwide.
Product
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1423-2023·2023-05-03
Biopsy forceps may fail to open when endoscope is bent
Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.
Product
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0542-2023·2023-05-03
Dianeal Low Calcium Dialysis Solution Recalled for Potential Sterility Loss
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution nationwide due to potential leaks from the container that could compromise sterility. Affected patients should contact their healthcare provider.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1436-2023·2023-05-03
Sterile surgical C-section kit light handle covers recalled for separation risk
ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2023·2023-05-03
VersaOne Reusable Positioning Cannula Recalled Due to Internal Metal Burrs
Covidien LP is recalling VersaOne Reusable Positioning Cannulas (Model RC12STS) due to manufacturing defects that may produce metal burrs on the inside of the device, potentially causing internal tissue damage during use.
Product
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2023·2023-05-03
Stryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings
Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.
Product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2023·2023-05-03
Surgical Convenience Kits Recalled for Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1429-2023·2023-05-03
Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring
The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.
Product
HAMILTON-C6, REF: 160021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1433-2023·2023-05-03
Sterile surgical kit recalled due to light handle cover separation risk
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2023·2023-05-03
Surgical Kit Light Handle Covers May Separate During Use
ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V219000·2023-05-03
2021 Forest River Berkshire Class A Motorhomes: Brake Light Reflection Defect
Forest River is recalling certain 2021 Berkshire Class A motorhomes due to brake lights that may not adequately reflect light. The defect affects visibility and compliance with Federal Motor Vehicle Safety Standards.
Product
FOREST RIVER — 2021 FOREST RIVER BERKSHIRE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0550-2023·2023-05-03
Prescription drug recall for manufacturing quality control deviations
Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0543-2023·2023-05-03
Peritoneal dialysis solution recalled due to sterility assurance concerns
Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2023·2023-05-03
VersaOne Reusable Positioning Cannula Recalled for Internal Metal Burr
Covidien LP is recalling 145 units of the VersaOne Reusable Positioning Cannula due to a manufacturing defect that may create a metal burr inside the device at the weld joint.
Product
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1470-2023·2023-05-03
Digital X-ray System Arm May Break, Posing Injury Risk
FUJIFILM's FDR AQRO digital X-ray system arm may break during use. The tube head support is susceptible to failure, which could cause serious harm to patients or operators.
Product
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1422-2023·2023-05-03
Surgical forceps may fail to open when endoscope shaft is bent
Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.
Product
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1469-2023·2023-05-03
Angiography system display malfunction affects diagnostic imaging capability
Siemens recalls the ARTIS one angiography system due to a hybrid cable display issue that may prevent image function on examination room monitors. Four US units are affected.
Product
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2023·2023-05-03
Lateral lumbar spine implant plate may disassemble during surgery
SPINEART's JULIET Ti LL lateral lumbar implant plates may disassemble during preparation or implant removal, causing surgical delays. The FDA is recalling 544 affected units distributed across eight US states.
Product
JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2023·2023-05-03
Draeger Infinity M300 Patient Monitor Software Displays Inaccurate ECG Readings
Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.
Product
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0555-2023·2023-05-03
FDA recalls Oxytocin product for low potency nationwide
SCA Pharmaceuticals is recalling Oxytocin 30 units in 0.9% Sodium Chloride solution (73,312 containers) nationwide due to subpotency—product contains insufficient active ingredient.
Product
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
Category
Drug
Distribution
Distributed nationwide