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.

4551–4575 of 76862

  • HighFDA (Devices)·Z-0323-2026·2025-11-05

    Endoscopic navigation platform recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 19 units of its EndoSNAP platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
    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 (Devices)·Z-0338-2026·2025-11-05

    Anti-siphon smallbore extension sets recalled over port weld separation risk

    ICU Medical is recalling 950 45-inch smallbore extension sets with an anti-siphon valve because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2026·2025-11-05

    Pyxis Pro auxiliary drawers recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 32 BD Pyxis Pro 7-Drawer Auxiliary 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 Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2026·2025-11-05

    Double port syringe transfer sets recalled over port weld separation risk

    ICU Medical is recalling 4,000 Double ChemoLock Port Syringe Transfer Sets because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2026·2025-11-05

    Soft tissue markers recalled over potential contamination with cotton fibers

    Endomagnetics is recalling 1,760 Magseed Pro 7 cm soft tissue markers because of the potential for contamination with cotton fibers.

    Product
    Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2026·2025-11-05

    Parathyroid hormone assay recalled over falsely depressed results at low range

    Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.

    Product
    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2026·2025-11-05

    Cardiac control material recalled over vial to vial troponin variability

    Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.

    Product
    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2026·2025-11-05

    Graduated adapter extension sets recalled over port weld separation risk

    ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.

    Product
    ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2026·2025-11-05

    20mm vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 11,200 ChemoLock Vented Vial Spikes, 20mm, 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 REF: CL-70S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2026·2025-11-05

    Mini bag spike connectors recalled over port weld separation risk

    ICU Medical is recalling 400 ChemoLock connectors with Mini Bag Spike because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2026·2025-11-05

    Purple cap administration sets recalled over port weld separation risk

    ICU Medical is recalling 11,000 31-inch administration sets with an integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.

    Product
    ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2026·2025-11-05

    SyncAR navigation platform recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
    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-0363-2026·2025-11-05

    ChemosafeLock bag spikes recalled over port weld separation risk

    ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0143-2026·2025-11-05

    Sodium chloride injection bags recalled over potential flexible container leaks

    Otsuka ICU Medical is recalling 509,360 100 mL bags of 0.9% Sodium Chloride Injection from one lot for lack of assurance of sterility due to potential flexible container leaks.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2026·2025-11-05

    Controlled substance safe towers recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 443 BD Pyxis CII Safe ES Tower Main units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2026·2025-11-05

    Vitrectomy probe accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 577 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' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2026·2025-11-05

    Unit dose prazosin 2 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 1,818 unit dose cartons of Prazosin Hydrochloride Capsules 2 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 (Devices)·Z-0365-2026·2025-11-05

    Chemotherapy vial adapters recalled because port weld may separate and leak

    ICU Medical is recalling 202,900 ChemosafeLock Vial Adapters because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2026·2025-11-05

    Testosterone and triamcinolone 87.5 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 21,324 sterile Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01
    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-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 (Devices)·Z-0331-2026·2025-11-05

    Clave bag spikes recalled because port weld may separate and leak

    ICU Medical is recalling 200 Clave Bag Spikes with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
    Category
    Medical Device
    Distribution
    Distributed nationwide