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.

14576–14600 of 20364

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
HighFDA (Devices)·Z-0921-2023·2023-01-18
Adult Craniotome Ball Bearing Separation Risk During Neurosurgery
The Anspach Adult Craniotome Large attachment ball bearings may separate during surgical removal or intra-operatively, potentially causing serious patient injury.
Product
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0099-2023·2023-01-18
Rocuronium Bromide Injection Recalled for Lack of Sterility Assurance
Rocuronium Bromide Injection syringes from Nephron Sterile Compounding Center are being recalled because the manufacturer cannot verify the product is sterile. The recall affects approximately 38,830 pre-filled syringes distributed nationwide.
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
Category
Drug
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-0939-2023·2023-01-18
HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.
Product
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0113-2023·2023-01-18
TriMix Injection Recall Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling TriMix Injection nationwide due to lack of assurance of sterility. The affected compounded injectable product comes in 2.5 mL vials with lot number 11142022@12.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/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 (Drugs)·D-0126-2023·2023-01-18
TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to inability to assure the product meets sterility standards required for injectable medications. The recall affects 2 vials distributed nationwide.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/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-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 (Devices)·Z-0923-2023·2023-01-18
Adult Craniotome Attachment Recalled for Ball Bearing Failure Risk
The ANSPACH CRANI-A Adult Craniotome Attachment is recalled because ball bearings can separate during use or removal, creating an intra-operative hazard. The Anspach Effort, Inc. is recalling 6,059 units distributed nationwide and internationally.
Product
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
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 (Drugs)·D-0124-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/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 (Drugs)·D-0103-2023·2023-01-18
QuadMix Plus Injectable Medication Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling QuadMix Plus injectable medication due to lack of assurance of sterility. The recall affects 78 vials distributed nationwide.
Product
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/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 (Drugs)·D-0118-2023·2023-01-18
TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling TriMix Injection (11.8mcg/18mg/0.6mg/mL) due to lack of assured sterility. Patients using affected vials should contact their healthcare provider immediately.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/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-0950-2023·2023-01-18
IMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues
Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.
Product
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KT
Category
Medical Device
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-0938-2023·2023-01-18
Syringe Kit Recall: Potential Sterility Breach from Outer Bag Leaks
Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.
Product
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0941-2023·2023-01-18
HCT MAX BARRIER PICC Insertion Tray Recalled for Potential Sterility Breach
Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.
Product
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2023·2023-01-18
DeRoyal surgical procedure pack recalled for sterile barrier defect
DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.
Product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
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-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 (Drugs)·D-0111-2023·2023-01-18
FDA Recalls Prostaglandin E1 Injection for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution due to lack of sterility assurance. The recall affects 108 vials distributed nationwide.
Product
Prostaglandin (E1) Injection Solution, 25mcg/ml, 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-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-0924-2023·2023-01-18
Pediatric Craniotome Recalled for Ball Bearing Detachment Risk
The Anspach Effort, Inc. is recalling 6,059 Pediatric Craniotome units (CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during surgery, potentially causing serious patient injury.
Product
Pediatric Craniotome Ref:CRANI-P-G1
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 (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