The Recall Desk

State

Maine product recalls

20,187 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.

7626–7650 of 20187

  • HighFDA (Devices)·Z-3121-2024·2024-09-18

    Medline Surgical Convenience Kits Recalled Due to Suction Loss Risk

    Medline Industries is recalling 1,076 surgical convenience kits due to reported adverse events from potential suction loss during use. Products were manufactured from September to November 2023.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D; c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F; d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C; e) LAMINE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3063-2024·2024-09-18

    Siemens Atellica CH diagnostic reagent batch may produce biased results

    A specific lot of Siemens Atellica CH urinary/cerebrospinal fluid protein reagent (lot 130414) may produce biased quality control results and inaccurate patient test outcomes. Approximately 229 units were distributed in the United States and 935 internationally.

    Product
    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3065-2024·2024-09-18

    Siemens Dimension Vista Bilirubin Reagent Cartridges Recalled Due to Underfilled Wells

    Siemens Healthcare Diagnostics is recalling one lot of Dimension Vista Total Bilirubin Flex Reagent Cartridges due to underfilled wells during manufacturing. The defect may result in inaccurate test results for calibrators, quality control, and patient samples.

    Product
    Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3124-2024·2024-09-18

    Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines

    Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.

    Product
    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3093-2024·2024-09-18

    Medline ReNewal Surgical Sealer/Divider Recalled for Incomplete Packaging Seal

    Medline Industries is recalling 2,860 units of its ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider due to potential incomplete seals on packaging trays, which could compromise sterility assurance.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3107-2024·2024-09-18

    Medline Surgical Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low suction during intermittent use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3076-2024·2024-09-18

    Syringes with Luer Slip Tips Recalled for Unapproved Design Modifications

    Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models because they are substantially different from FDA-approved designs and include major modifications to their intended use without approval.

    Product
    Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 8403685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3089-2024·2024-09-18

    Proton Therapy System Software Allows Safety Verification Mechanisms to Be Disabled

    The IBA Proton Therapy System (PROTEUS 235 and related models) has a software defect allowing safety parameter verification mechanisms to be deactivated during clinical use. This affects 35 units distributed worldwide.

    Product
    IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2975-2024·2024-09-18

    HeNe Laser System Allows Key Removal While Operating

    Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.

    Product
    25-LHP-828, HeNe Laser System, 35 mW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3127-2024·2024-09-18

    Proton Therapy System May Display Insufficient Images During Treatment Planning

    FDA recalls the PROBEAT-V proton beam therapy system due to a software issue where the 3D image positioning mode may display insufficient images, potentially affecting treatment planning accuracy.

    Product
    Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3109-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling 407 units of semi-rigid suction liners manufactured between September and November 2023 due to potential loss of suction during intermittent use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B; d) NASAL FESS, Pack Number DYNJ908105B; e) NASAL-LF, Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3115-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled Due to Loss of Suction

    Medline is recalling 444 NICU admit kits containing semi-rigid suction liners due to potential loss or low suction during intermittent use. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3092-2024·2024-09-18

    Medline ReNewal Reprocessed LigaSure Blunt Tip Recalled for Packaging Seal Defect

    Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2976-2024·2024-09-18

    HeNe Laser System Key Control Can Be Removed While Operating

    PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.

    Product
    25-LHP-928, HeNe Laser System, 25 mW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3106-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss

    Medline Industries is recalling anesthesia circuit kits due to reported adverse events indicating potential loss of suction during intermittent use. Approximately 29,585 units distributed in the US, Canada, and Panama are affected.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C; c) ANESTHESIA CIRCUIT ADULT, Pack Number DYNJAA0378A; d) ADULT ANESTHESIA CIRC LAGUNA, Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3116-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss

    Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3064-2024·2024-09-18

    ADVIA Chemistry urinary protein reagent quality control failure

    Siemens Healthcare is recalling ADVIA Chemistry urinary protein test reagents due to potential quality control issues that could produce inaccurate patient results.

    Product
    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3102-2024·2024-09-18

    Siemens Atellica IM CA 19-9 Test Kit Recall: Measurement Bias in Samples

    Siemens is recalling Atellica IM CA 19-9 test kits (Lot 56434535) due to positive bias in measurement of tumor marker levels in some samples, particularly from Asia Pacific regions.

    Product
    Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1807-2024·2024-09-18

    American Outdoor Products Astronaut Strawberries Recalled for Elevated Lead Levels

    American Outdoor Products' Astronaut Strawberries are being recalled due to elevated lead levels. The recall affects approximately 14,235 units distributed nationwide.

    Product
    American Outdoor Products - Astronaut Strawberries, packaged in 0.5oz (14g) metallic plastic pouches. Sold individually or in 6, 12, 40, or 160 count cases. One unit is also included in the Outerspace Survival Dessert Kit. Shelf stable.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3075-2024·2024-09-18

    SOL-CARE and SOL-M syringes recalled for unapproved design modifications

    Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M syringes with safety needles because the devices are substantially different from FDA-cleared versions, with major modifications to intended use.

    Product
    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2977-2024·2024-09-18

    HeNe laser system recalled for removable key safety control defect

    Pacific Lasertech is recalling the N-LHP-928 HeNe Laser System (35 mW) because the key-actuated safety control can be removed while the laser is operating, defeating the required master control mechanism.

    Product
    N-LHP-928, HeNe Laser System, 35 mW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0657-2024·2024-09-18

    Barrier Therapy Skin Protectant Cream recalled for microbial contamination

    Prequel Skin is recalling Barrier Therapy Skin Protectant Cream due to microbial contamination. The recall affects approximately 30,946 tubes distributed nationwide and online.

    Product
    BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3122-2024·2024-09-18

    FilmArray 2.0 Diagnostic Instruments Recalled for Calibration Error Affecting Test Results

    BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.

    Product
    FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3110-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling specific convenience kits with semi-rigid suction liners due to reported adverse events and potential loss of suction during intermittent use. Affected: 358 units distributed in US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3133-2024·2024-09-18

    Biolox Taper Sleeve Mislabeling: Wrong Component Size in Hip Replacement

    Zimmer GmbH is recalling Biolox Option Taper Sleeves due to mislabeling where packaging labels one neck size but contains the opposite size. These components are used in hip replacement surgery.

    Product
    Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
    Category
    Medical Device
    Distribution
    Distributed nationwide