The Recall Desk

State

Maine product recalls

72,968 recalls have nationwide distribution and so reach Maine. 3,894 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total
3,894
Critical
468
Severe
791
Most recent
2026-09-02

Of the 3,894 recalls naming Maine we have scored against our rubric, 468 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 791 (20%) are Severe.

These figures cover only the 3,894 recalls whose distribution notice names Maine specifically. The 72,968 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4601–4625 of 76862

  • HighFDA (Devices)·Z-0378-2026·2025-11-05

    Infusion pumps recalled over phantom touches on the touchscreen corner

    Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2026·2025-11-05

    Chemotherapy extension sets recalled because port weld may separate during use

    ICU Medical is recalling 2,450 8-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2026·2025-11-05

    Unit dose prazosin 5 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0126-2026·2025-11-05

    Testosterone 87.5 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 529 sterile Testosterone 87.5 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2026·2025-11-05

    Surgical imaging software recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2026·2025-11-05

    Sample preparation systems recalled over incorrect dead volumes in instructions

    Beckman Coulter is recalling 108 CellMek SPS sample preparation systems because the instructions for use list incorrect dead volumes and the software does not rock Cassette E.

    Product
    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2026·2025-11-05

    Syringe transfer sets recalled because port weld may separate and leak

    ICU Medical is recalling 900 Syringe Transfer Sets with MicroClave and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0130-2026·2025-11-05

    Testosterone and triamcinolone 12.5 mg pellets recalled over metal particulate

    FarmaKeio Outsourcing is recalling 18,124 sterile Testosterone / Triamcinolone Acetonide 12.5MG/2.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2026·2025-11-05

    BrainSTORM surgical planner recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling three units of its BrainSTORM Surgical Planner because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0144-2026·2025-11-05

    Pulled pork sandwiches recalled over potential plastic foreign material

    E.A. Sween Co. is recalling 32,732 cases, 327,320 individual units, of Deli Express BBQ Pulled Pork on a sesame bun over potential plastic foreign material.

    Product
    Deli Express BBQ Pulled Pork on a sesame bun. Net Wt 5.5oz (156g) UPC 0 41433-03087 5. EA Sween Company, Eden Prairie, MN 55344.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0131-2026·2025-11-05

    Combination hormone pellets recalled over potential presence of metal particulate matter

    FarmaKeio Outsourcing is recalling 36,924 sterile Testosterone / Triamcinolone Acetonide 25MG/5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0413-2026·2025-11-05

    Blood glucose meters recalled over display segments that can misread values

    Trividia Health is recalling 601 Good Neighbor Pharmacy TRUE METRIX blood glucose meters over a display defect that can cause glucose values to be misread.

    Product
    Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2026·2025-11-05

    Vented vial spikes recalled because port weld may break during use

    ICU Medical is recalling 80 units of ChemoLock Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0111-2026·2025-11-05

    Desipramine 100 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 5,882 bottles of Desipramine Hydrochloride Tablets USP 100 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2026·2025-11-05

    Testosterone and triamcinolone 100 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 103,444 sterile Testosterone / Triamcinolone Acetonide 100MG/20MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0362-2026·2025-11-05

    Oncology kits recalled because a port weld may separate and leak

    ICU Medical is recalling 200 Oncology Kits with two ChemoLock components because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2026·2025-11-05

    Desipramine 75 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 2,418 bottles of Desipramine Hydrochloride Tablets USP 75 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2026·2025-11-05

    Testosterone 50 mg pellets recalled over potential presence of metal particulate

    FarmaKeio Outsourcing is recalling 829 sterile Testosterone 50 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2026·2025-11-05

    Chandelier illuminators recalled over incomplete seals in the sterile pouch

    Alcon Research is recalling 330 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Softwa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2026·2025-11-05

    Testosterone 62.5 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 829 sterile Testosterone 62.5 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2026·2025-11-05

    Pyxis Medbank units recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 8,262 BD Pyxis Medbank units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2026·2025-11-05

    Trocar sealing caps recalled over silicone fragments detaching from sealing component

    Aesculap is recalling 140 sealing caps for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.

    Product
    Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2026·2025-11-05

    Entry system accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2026·2025-11-05

    21 inch extension sets recalled over port weld separation risk

    ICU Medical is recalling 950 21-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2026·2025-11-05

    Testosterone and triamcinolone 50 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 64,924 sterile Testosterone / Triamcinolone Acetonide 50MG/10MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
    Category
    Drug
    Distribution
    Distributed nationwide