The Recall Desk

State

Maine product recalls

73,596 recalls have nationwide distribution and so reach Maine. 3,922 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total
3,922
Critical
476
Severe
966
Most recent
2026-09-23

Of the 3,922 recalls naming Maine we have scored against our rubric, 476 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 966 (25%) are Severe.

Which agencies issued them

These figures cover only the 3,922 recalls whose distribution notice names Maine specifically. The 73,596 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1851–1875 of 77518

  • SevereFDA (Devices)·Z-2382-2026·2026-06-24

    Arrow drainage and thoracentesis kits contain recalled supplier drugs

    Arrow drainage and thoracentesis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 444,943 units are affected.

    Product
    Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2381-2026·2026-06-24

    Arrow 12 Fr hemodialysis kit contains drugs from a recalled supplier

    The Arrow two-lumen 12 Fr x 16 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,945 units affected.

    Product
    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2366-2026·2026-06-24

    Arrow pacing PSI kits contain drugs from a recalled supplier

    Arrow Pacing PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,915 units are affected.

    Product
    Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2374-2026·2026-06-24

    Arrow AHDC catheter kits contain drugs from a recalled supplier

    Arrow AHDC three-lumen catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 4,270 units affected.

    Product
    Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2376-2026·2026-06-24

    Arrow central venous catheter kits contain drugs from a recalled supplier

    Arrow central venous catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 308,263 units affected.

    Product
    Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2373-2026·2026-06-24

    Arrow hemodialysis catheter kits contain drugs from a recalled supplier

    Arrow two-lumen hemodialysis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,425 units affected.

    Product
    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2026·2026-06-24

    ConMed AirSeal 12mm access ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 891 packs, or 5,346 units, are affected.

    Product
    ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2026·2026-06-24

    iLet Bionic Pancreas pumps may become stuck on the lock screen

    The iLet Bionic Pancreas is being recalled because a screen unlock failure can leave the user stuck on the Lock Screen, unable to change the cartridge or announce a meal.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2483-2026·2026-06-24

    Medline 14 Fr coude latex catheters fail performance specifications

    Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 14 Fr, are being recalled across all lots because samples did not meet performance specifications. 8,260 units affected.

    Product
    MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2026·2026-06-24

    Inspire respiratory sensing leads labeled with Use By dates beyond shelf life

    Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2026·2026-06-24

    STAAR ICL calculation software miscalculates toric lens orientation diagram printout

    STAAR ICL Calculation Software version 8.00 is being recalled because of a coding issue in calculating the implantation orientation diagram printout for toric implantable collamer lenses.

    Product
    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2026·2026-06-24

    Medline red rubber urethral catheterization trays fail performance specifications

    Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots because samples did not meet performance specifications. 235,658 units affected.

    Product
    MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2518-2026·2026-06-24

    HeartMate 3 assist system kits recalled over backup battery failures

    HeartMate 3 Left Ventricular Assist System kits, model 106524US, are being recalled due to 11 volt backup battery failures. Four units are affected.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2484-2026·2026-06-24

    Medline coude latex catheters fail applicable performance specifications

    Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.

    Product
    MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2478-2026·2026-06-24

    Mito Red Light Super Mobile batteries may catch fire

    The Mito Red Light Super Mobile near-infrared therapy device is being recalled because its lithium-ion battery may malfunction, causing it to catch fire or burst into flames.

    Product
    Mito Red Light, Super Mobile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2026·2026-06-24

    Medline red rubber urethral catheters fail applicable performance specifications

    Medline Urethral Catheters in red rubber latex, spanning French sizes 08 to 22, are being recalled because samples did not meet performance specifications. 2,237,471 units affected.

    Product
    MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2026·2026-06-24

    HeartMate 3 system controllers recalled over backup battery failures

    HeartMate 3 System Controllers, model 106531US, are being recalled due to 11 volt backup battery failures. 694 units are affected.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2480-2026·2026-06-24

    Medline 15 Fr urethral catheterization trays fail performance specifications

    Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled because samples did not meet performance specifications. 8,327,756 units are affected.

    Product
    MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2026·2026-06-24

    Medline cardiovascular draping and basin kits contain substandard catheters

    Medline CV Draping/Basin procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,432 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 150mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 150 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2026·2026-06-24

    Medline retina procedure kits contain catheters failing performance specifications

    Medline Retina LAC/USC CDS procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 2,340 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2490-2026·2026-06-24

    Medline oral restoration kits contain catheters failing performance specifications

    Medline Oral Restoration procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications.

    Product
    MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2493-2026·2026-06-24

    Medline procedure kits contain catheters failing performance specifications

    Medline medical procedure kits including ECMO chest exploration, coronary artery bypass and D&C/cysto trays are being recalled because sample catheters did not meet performance specifications.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO, Medline Kit Number/SKU DYNJ909989B; 4) DDD LAPAROSCOPY PACK, Medline Kit Number/SKU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2026·2026-06-24

    Giraffe OmniBed replaceable units share the canopy fastener disengagement defect

    Giraffe OmniBed Field Replaceable Units are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 265 units affected.

    Product
    Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2026·2026-06-24

    HeartMate 11 volt lithium ion backup batteries may fail

    HeartMate 11 Volt Lithium Ion Standalone Backup Batteries, model 106128, are being recalled due to 11 volt backup battery failures. Twelve units are affected.

    Product
    Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power…
    Category
    Medical Device
    Distribution
    Distributed nationwide