The Recall Desk

State

Montana product recalls

72,940 recalls have nationwide distribution and so reach Montana. 3,567 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,567
Critical
689
Severe
783
Most recent
2026-09-02

Of the 3,567 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 783 (22%) are Severe.

Which agencies issued them

These figures cover only the 3,567 recalls whose distribution notice names Montana specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4826–4850 of 76507

  • HighFDA (Devices)·Z-0145-2026·2025-10-22

    Shoulder surgical planning software recalled over possible implant malalignment risk

    Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.

    Product
    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative mea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0022-2026·2025-10-22

    Sunscreen lotion recalled after failing total aerobic microbial count testing

    SV Labs Prescott is recalling 11,386 tubes of Aloe Up Sport Performance Sunscreen Lotion SPF 30 after the firm released and distributed product that failed total aerobic microbial count testing.

    Product
    Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2026·2025-10-22

    Preconnect pump devices recalled over inflation and deflation performance issues

    Boston Scientific is recalling 172 CXR Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2026·2025-10-22

    Non-DEHP Continu-Flo sets recalled from one lot because sets may leak

    Baxter is recalling 48,096 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2026·2025-10-22

    Twelve foot display cables recalled over inadequate shielding and interference

    Spacelabs Healthcare is recalling 820 twelve-foot DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2026·2025-10-22

    General and laparotomy packs recalled after being sterilized more than once

    American Contract Systems is recalling general, chest, laparotomy and interventional radiology convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2026·2025-10-22

    Cardiac Workstation 7000 recalled after pinched power module wire caused short

    Philips is recalling 29 Cardiac Workstation 7000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.

    Product
    Cardiac Workstation 7000; Model Number: 860441;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2026·2025-10-22

    Cystoscopy procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling cysto convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2026·2025-10-22

    Eye and cataract packs recalled after being sterilized more than once

    American Contract Systems is recalling cataract, eye, retinal and vitrectomy convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2026·2025-10-22

    Wound dressings recalled because foreign matter may be on the product

    ConvaTec is recalling 80,980 DuoDERM Extra Thin dressings from one lot because the wound dressing may have foreign matter on the product.

    Product
    DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2026·2025-10-22

    Three valve solution sets recalled from one lot because sets may leak

    Baxter is recalling 12,720 CLEARLINK System Continu-Flo solution sets with three luer activated valves from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2026·2025-10-22

    LGX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2026·2025-10-22

    PICC and gastrostomy tube packs recalled after being sterilized more than once

    American Contract Systems is recalling PICC G-Tube convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2026·2025-10-22

    Three valve retractable collar sets recalled across many lots for leak potential

    Baxter is recalling 1,167,120 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2026·2025-10-22

    Basic biopsy trays recalled after entire lot was sterilized more than once

    American Contract Systems is recalling a Basic Biopsy Tray lot that was re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Basic Biopsy Tray, Item Number NMBP44L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2026·2025-10-22

    Caesarean section packs recalled after being sterilized more than once

    American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2026·2025-10-22

    Cyclodialysis surgical instruments recalled over compromised sterile packaging integrity

    Iantrek is recalling 1,262 CycloPen Microinterventional Cyclodialysis Systems over the potential for compromised integrity of the sterile packaging.

    Product
    Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2026·2025-10-22

    Retractable collar solution sets recalled across many lots because sets may leak

    Baxter is recalling 958,351 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2026·2025-10-22

    Fourteen inch extension sets recalled from one lot because sets may leak

    Baxter is recalling 2,304 CLEARLINK System straight-type extension sets with a retractable collar from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2026·2025-10-22

    Paclitaxel infusion sets recalled from one lot because IV sets may leak

    Baxter is recalling 27,072 CLEARLINK System Paclitaxel Sets from one lot because the IV sets may leak.

    Product
    CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2026·2025-10-22

    LOGIQ P10 HD systems recalled over inaccurate liver steatosis measurement values

    GE is recalling 31 LOGIQ P10 R4.5 HD ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    Product
    LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2026·2025-10-22

    Biopsy and laparoscopy packs recalled after being sterilized more than once

    American Contract Systems is recalling biopsy and laparoscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2026·2025-10-22

    LGX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide