The Recall Desk

State

Maine product recalls

20,371 recalls have nationwide distribution and so reach Maine. 0 additional recalls listed Maine specifically in their distribution scope.

About recalls in Maine

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 Maine 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.

15626–15650 of 20371

  • HighFDA (Devices)·Z-1678-2022·2022-09-14

    External Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient

    OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.

    Product
    Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2022·2022-09-14

    VITROS XT 3400 Chemistry System May Produce Inaccurate Test Results

    The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.

    Product
    VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1496-2022·2022-09-14

    Sodium Chloride Ophthalmic Ointment Recalled for Turbidity and Sterility Concerns

    Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment due to turbidity found during sterility testing. The FDA expanded the recall to additional lots sharing potential root cause.

    Product
    Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1495-2022·2022-09-14

    Lidocaine Hydrochloride Jelly Recalled Due to cGMP Deviations and Turbidity

    Akorn, Inc. is recalling 82,689 tubes of Lidocaine Hydrochloride Jelly USP, 2%, due to cGMP deviations and turbidity discovered during sterility testing. The recall affects multiple lots distributed nationwide.

    Product
    Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2022·2022-09-14

    CARTO VIZIGO Guiding Sheath Recalled Due to Water-Damaged Sterile Packaging

    Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.

    Product
    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2022·2022-09-14

    Medline Chest Tube Kit Recalled for Non-Sterile Tape Component

    Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.

    Product
    Medline CHEST TUBE REORDER NO: DYNJ36762A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1487-2022·2022-09-14

    Calcium Carbonate Oral Suspension Recalled Due to Manufacturing Control Deviations

    Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.

    Product
    CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1480-2022·2022-09-14

    FDA Recalls Milk of Magnesia USP for Manufacturing Control Deviations

    Plastikon Healthcare LLC is recalling 502,600 cups of Milk of Magnesia USP due to manufacturing process control deviations. Consumers should discontinue use and consult their healthcare provider if concerned.

    Product
    MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1486-2022·2022-09-14

    Acetaminophen Oral Solution Recalled for Manufacturing Process Control Failures

    Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.

    Product
    Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1499-2022·2022-09-14

    Difluprednate Eye Drops Recalled for Defective Container Sterility Risk

    Cipla is recalling 117,844 bottles of Difluprednate eye drops nationwide due to defective containers where the protective cap can break, potentially exposing the dropper tip and compromising sterility.

    Product
    DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2022·2022-09-14

    ChemoLock Chemotherapy Port Connectors Recalled for Disconnection Risk

    ICU Medical recalls ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to spring defects that may prevent proper connection or cause unintended disconnection, potentially delaying treatment or exposing patients to caustic substances.

    Product
    Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Dri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1493-2022·2022-09-14

    CORRECTDOSE Children's Pain Relief and Fever Reducer Acetaminophen Recalled for Manufacturing Control Violations

    CORRECTDOSE Children's Fever Reducer (160 mg/5 mL acetaminophen) has been recalled due to manufacturing control deviations. The recall affects 1,464 units distributed nationwide.

    Product
    CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1498-2022·2022-09-14

    Difluprednate Eye Drops Recalled for Defective Container Compromising Sterility

    CIPLA is recalling 3,468 bottles of Difluprednate Ophthalmic Emulsion nationwide due to defective protective caps that could expose the dropper tip and compromise sterility. No injuries have been reported.

    Product
    Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1491-2022·2022-09-14

    Guaifenesin and Dextromethorphan Cough Syrup Recalled for Manufacturing Control Deviations

    Plastikon Healthcare LLC is recalling Guaifenesin and Dextromethorphan cough syrup cups distributed nationwide due to manufacturing processes that were not adequately controlled.

    Product
    GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1686-2022·2022-09-14

    King's Hawaiian Pretzel Buns Recalled for Potential Bacterial Contamination

    King's Hawaiian pretzel hamburger buns, slider buns, and pretzel bites are recalled nationwide. An ingredient used in manufacturing may contain Cronobacter sakazakii or Clostridium botulinum.

    Product
    King's Hawaiian 10.5 oz. Pretzel Hamburger Buns (UPC 73435000365), 10.2 oz. Pretzel Bites (UPC 73435000525.), and 11 oz. Slider Buns (UPC 73435000372 ) packed in plastic bags. Distributed by King s Hawaiian Bakery West, Inc., 19161 Harborgate Way, Torrance, CA 90501
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2022·2022-09-14

    ChemoLock Infusion Ports Recalled for Unintended Disconnection Risk

    ICU Medical recalls ChemoLock chemotherapy infusion ports for potential unintended disconnection due to spring variation, which may delay therapy and expose patients to caustic substances.

    Product
    Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1494-2022·2022-09-14

    Children's Cough Medicine Recalled for Manufacturing Control Deficiency

    CORRECTDOSE Children's Cough & Chest Congestion DM is being recalled nationwide due to manufacturing process control deviations that did not meet required quality standards.

    Product
    CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1489-2022·2022-09-14

    Diphenhydramine HCl Oral Solution Recalled for Manufacturing Process Deviations

    Plastikon Healthcare LLC is recalling 349,100 cups of Diphenhydramine HCl Oral Solution due to manufacturing process control deviations. The product was distributed nationwide for institutional use only.

    Product
    Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6741-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1484-2022·2022-09-14

    Acetaminophen Oral Solution 160 mg Recalled for Manufacturing Control Deviations

    Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.

    Product
    Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1488-2022·2022-09-14

    Diphenhydramine Solution Recalled Due to Manufacturing Control Deviations

    Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.

    Product
    Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2022·2022-09-14

    Early Bird Bleed Monitoring System Introducer fails to power on

    Saranas, Inc. is recalling 953 units of the Early Bird Bleed Monitoring System Introducer Sheath Set due to a design error that prevents the device from powering on and completing self-tests. The product was distributed nationwide.

    Product
    Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2022·2022-09-14

    Handheld ultraviolet-C germicidal wand recalled for excessive radiation

    MERCHSOURCE LLC is recalling a handheld ultraviolet-C germicidal wand (model 1013622) due to excessive ultraviolet-C radiation emission. Consumers should stop using the product immediately.

    Product
    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2022·2022-09-14

    Laboratory diagnostic system may report inaccurate results during shutdown

    The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.

    Product
    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1492-2022·2022-09-14

    CORRECTDOSE Children's Allergy Relief Recalled Due to Manufacturing Process Control Deviations

    CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.

    Product
    CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1485-2022·2022-09-14

    Acetaminophen Oral Solution Recalled Due to Manufacturing Control Deviations

    Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution nationwide because manufacturing quality controls were not adequately maintained. Affected product was distributed to institutional healthcare settings.

    Product
    Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71
    Category
    Drug
    Distribution
    Distributed nationwide