The Recall Desk

State

Maine product recalls

72,992 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 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7201–7225 of 76886

  • HighFDA (Devices)·Z-1427-2025·2025-04-02

    CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues

    St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.

    Product
    CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1436-2025·2025-04-02

    Medline Procedure Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling angiography and catheterization procedure kits containing plastic syringes that may leak or break. The recalled kits affect 1939 units distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid Plus software issue affects emergency mode operation

    Baxter is recalling 48 TruSystem 7500 Hybrid Plus units due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled.

    Product
    Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode

    Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.

    Product
    Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk

    The adhesive on Checkpoint Guardian Intraoperative Leads may not fully cover metallic wire components, leading to potential electrical current leakage. This could result in inconsistent muscle responses and affect surgical effectiveness.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1422-2025·2025-04-02

    Software Malfunction Disables Back Control on Baxter TruSystem 7500

    Baxter TruSystem 7500 medical devices are affected by a software issue that prevents the upper back section from operating when emergency mode is enabled. Approximately 1,709 units have been recalled nationwide.

    Product
    Baxter TruSystem 7500, Product Code 4091000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid IMRIS Upper Back Adjustment Software Malfunction

    A software issue in the Baxter TruSystem 7500 Hybrid MR IMRIS system prevents the upper back section from being adjusted when emergency mode is enabled. The recall affects 24 units distributed nationwide.

    Product
    Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2025·2025-04-02

    Baxter Operating Table Column Software Issue Limits Emergency Mode Function

    Baxter Healthcare is recalling 403 TS7500 MOBIUS operating table columns due to a software issue that prevents the upper back section from being adjustable when emergency mode is activated.

    Product
    Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0293-2025·2025-04-02

    Strides Pharma Testosterone Gel Recalled Due to Benzene Contamination

    Strides Pharma is recalling Testosterone Gel 1% (195,952 cartons nationwide) due to benzene contamination. Consumers using affected lots should immediately contact their healthcare provider.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2025·2025-04-02

    Medline C-section procedure kits recalled for syringe quality defects

    Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.

    Product
    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage

    Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2025·2025-04-02

    Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings

    Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.

    Product
    namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2025·2025-04-02

    Medline procedure kits with defective plastic syringes recalled due to leak and breakage risk

    Medline procedure kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may compromise sterile medical procedures. Approximately 14,589 units were distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2025·2025-04-02

    Medline Procedure Kits Recalled for Syringe Quality Defects

    Medline procedure kits with defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall involves 422 units distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0303-2025·2025-04-02

    Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue

    Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2025·2025-04-02

    Medline arthroscopy procedure kits recalled for defective plastic syringes

    Medline is recalling arthroscopy procedure kits containing plastic syringes with defects including leaks and breakage. The syringes may pose a risk to patient health during surgical procedures.

    Product
    Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2025·2025-04-02

    Medline Pressure Monitoring Kits Recalled for Luer Fitting Manufacturing Defect

    Medline Industries is recalling 1,669 pressure monitoring line convenience kits distributed worldwide. The female luer fittings contain excess material near the fluid pathway.

    Product
    namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,ME
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2025·2025-04-02

    Medline medical procedure kits recalled for plastic syringe defects

    Medline procedure kits with plastic syringes are being recalled due to potential leaks and breakage that may affect patient safety. The recall impacts 1152 units distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2025·2025-04-02

    Medline General Endoscopy Procedure Kit Recalled Due to Syringe Defects

    Medline is recalling General Endoscopy procedure kits due to plastic syringe defects that may leak or break. The affected kits pose potential risk to patient health during medical procedures.

    Product
    Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries is recalling 1,228 surgical procedure kits containing defective plastic syringes. The syringes may leak or break during use, potentially affecting patient safety.

    Product
    Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2025·2025-04-02

    Baxter surgical table software issue blocks emergency back adjustment

    Baxter is recalling 112 units of the TruSystem 7500 surgical table due to a software issue preventing upper back adjustment during emergency mode. No injuries have been reported.

    Product
    Baxter Floor mounting column TruSystem 7500, Product Code 1717021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2025·2025-04-02

    Medline Medical Procedure Kits With Plastic Syringes Recalled for Quality Issues

    Medline medical procedure kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2025·2025-04-02

    Medline Procedure Kits With Defective Syringes Recalled Nationwide

    Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.

    Product
    Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
    Category
    Medical Device
    Distribution
    Distributed nationwide