State

Montana product recalls

73,576 recalls have nationwide distribution and so reach Montana. 3,572 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total: 3,572
Critical: 689
Severe: 952
Most recent: 2026-10-14

Of the 3,572 recalls naming Montana we have scored against our rubric, 689 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 952 (27%) are Severe.

Which agencies issued them

These figures cover only the 3,572 recalls whose distribution notice names Montana specifically. The 73,576 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

27026–27050 of 77148

HighFDA (Devices)·Z-1054-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-401D-1321 aspiration needles because inspection found inadequate package seals, posing a risk of infection if non-sterile equipment is used.
Product
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1043-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects
Aomori Olympus is recalling 260,395 NeedleMaster needles in the US because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2021·2021-02-17
Aomori Olympus Recalls KD-650L Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-650L Electrosurgical Snare units because some sterile packages have inadequate seals, posing an infection risk.
Product
KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0964-2021·2021-02-17
Aomori Olympus Recalls B7-2LA Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B7-2LA Balloon Catheters because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.
Product
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1059-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling Vizishot 21G aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0955-2021·2021-02-17
ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices were distributed in the U.S. and Belgium.
Product
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2021·2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Package Seal Defects
Aomori Olympus is recalling endoscopic injectors because some sterile packages have inadequate seals, which could lead to infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1002-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0986-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-210U-25 electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection.
Product
SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2021·2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Package Seal Defects
Aomori Olympus is recalling endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1108-2021·2021-02-17
Helena Laboratories Recalls Cascade Abrazo aPTT Test Cards for Clot Time Issues
Helena Laboratories is recalling Cascade Abrazo aPTT Test Cards due to intermittent potential for shorter than expected clot times.
Product
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, which could lead to patient infection.
Product
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2021·2021-02-17
Aomori Olympus Recalls ForceMax Lower Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax Lower injectors because some sterile packages have inadequate seals, posing an infection risk if used.
Product
INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21081·2021-02-17
Jimco Recalls J Hunt Home Accent Tables Due to Shock Hazard
Jimco Lamp is recalling J Hunt Home accent tables with charging receptacles due to a shock hazard caused by reverse polarity. No injuries have been reported.
Product
J Hunt Home and J Hunt and Co. Accent Tables with Charging Receptacles
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2021·2021-02-17
Aomori Olympus Recalls B7-2C Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B7-2C Balloon Catheters because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.
Product
B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0959-2021·2021-02-17
Prytime Medical REBOA Catheter Introducer Kit Recalled for Incorrect Needle Size
Prytime Medical Devices is recalling REBOA Catheter Introducer Kits because they may contain a 21G needle instead of the correct 18G needle, which could cause procedure delays or injury.
Product
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1090-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material.
Product
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1096-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects
Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1079-2021·2021-02-17
Cardinal Health Recalls Chembloc Preparation Kits Due to Gown Defects
Cardinal Health is recalling Chembloc Preparation and Administration Kits because the included gowns may have rips, holes, or foreign material.
Product
CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1107-2021·2021-02-17
Phadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results
Phadia US Inc is recalling EliA dsDNA Well kits because decreased positive control values may cause false positive test results for systemic lupus erythematosus.
Product
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0956-2021·2021-02-17
ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 smallbore intravascular administration sets because of an incorrect filter assembly. The affected lots were distributed nationwide and in Belgium.
Product
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1095-2021·2021-02-17
Cardinal Health Recalls Kendall Blue Isolation Gowns Due to Defects
Cardinal Health is recalling Kendall Blue Isolation Gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material…
Category
Medical Device
Distribution
Distributed nationwide