The Recall Desk

State

Montana product recalls

73,584 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.

These figures cover only the 3,572 recalls whose distribution notice names Montana specifically. The 73,584 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

27351–27375 of 77156

  • SevereFDA (Drugs)·D-0205-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,890 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0210-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 14,580 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2021·2021-01-13

    SCA Pharmaceuticals Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,275 syringes of Lidocaine HCl 2% because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0217-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 9,942 syringes of Ketamine 50 mg/5mL injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0192-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 996 fentanyl and bupivacaine syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0213-2021·2021-01-13

    SCA Pharmaceuticals Recalls ePHEDrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling ePHEDrine 25 mg/5 mL Injection syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0211-2021·2021-01-13

    SCA Pharmaceuticals Recalls Rocuronium Br Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 13,096 syringes of Rocuronium Br 50 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0778-2021·2021-01-13

    Boston Scientific Recalls Hot AXIOS Stent Delivery Systems Due to Detachment Risk

    Boston Scientific is recalling 78 units of Hot AXIOS Stent and Electrocautery delivery systems because a fitting may detach, risking peritonitis.

    Product
    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,092 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,152 single-dose syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0800-2021·2021-01-13

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling 40 enGen Laboratory Automation Systems due to a software anomaly that may cause sample mislabeling, potentially leading to incorrect patient results and inappropriate medical intervention.

    Product
    enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2021·2021-01-13

    SCA Pharmaceuticals Recalls Rocuronium Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,940 syringes of Rocuronium Br 100 mg/10mL because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2021·2021-01-13

    SCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.

    Product
    Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0214-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0176-2021·2021-01-13

    Merck Recalls Zerbaxa Injection Vials Due to Sterility Test Failures

    Merck Sharp & Dohme is recalling 106,503 vials of Zerbaxa (ceftolozane and tazobactam) injection because sterility tests on related batches failed.

    Product
    ZERBAXA — ZERBAXA (CEFTOLOZANE AND TAZOBACTAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0198-2021·2021-01-13

    SCA Pharmaceuticals Recalls Labetalol HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 9,057 syringes of labetalol HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0773-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment

    Boston Scientific is recalling 13 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 116 Morphine Sulfate syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0191-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2021·2021-01-13

    Ortho-Clinical VITROS Automation Software Recall for Sample Labeling Errors

    Ortho-Clinical Diagnostics is recalling VITROS Automation Solutions software due to a defect that may cause samples to be mislabeled, potentially leading to incorrect patient results.

    Product
    VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2021·2021-01-13

    Roche CoaguChek XS Prof Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS Prof meters because they may display results in incorrect units, potentially leading to misinterpretation of warfarin monitoring data.

    Product
    CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2021·2021-01-13

    DePuy Pinnacle Hip Cups Recalled for Potential Cross-Threaded Apex HE Fixation

    DePuy Orthopaedics is recalling Pinnacle Hip Cups because the Apex HE screw may thread through the cup shell without stopping, potentially protruding internally.

    Product
    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2021·2021-01-13

    Roche CoaguChek XS PST Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS PST meters because they may display blood-clotting results in the wrong units. Users should verify their meter is set to INR.

    Product
    CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment Risk

    Boston Scientific is recalling 32 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide