The Recall Desk

State

Massachusetts product recalls

72,907 recalls have nationwide distribution and so reach Massachusetts. 8,208 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,208
Critical
1,171
Severe
2,012
Most recent
2026-09-09

Of the 8,208 recalls naming Massachusetts we have scored against our rubric, 1,171 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,012 (25%) are Severe.

These figures cover only the 8,208 recalls whose distribution notice names Massachusetts specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1201–1225 of 81115

  • 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 to
    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-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-2481-2026·2026-06-24

    Medline pre-connected urethral catheterization trays fail performance specifications

    Medline Pre-connected Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots. The action covers 4,304,669 units.

    Product
    MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407
    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 pres
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2506-2026·2026-06-24

    Medline urology and gynaecology kits contain catheters failing specifications

    Medline procedure kits including robotic cystectomy, D&C and lithotomy packs are being recalled because sample catheters did not meet performance specifications. 32,438 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)
    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-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-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-2470-2026·2026-06-24

    ConMed AirSeal 5mm 120mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2026·2026-06-24

    Medline bioburden test and cystectomy kits contain substandard catheters

    Medline procedure kits including the Bioburden Test Kit and Kit Uro Robot Cystectomy are being recalled because sample catheters did not meet performance specifications. 123,030 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2026·2026-06-24

    Medline carotid neuro and VP shunt packs contain substandard catheters

    Medline Carotid Neuro Packs and VP Shunt CDS kits are being recalled because representative samples did not meet applicable catheter performance specifications. 342 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2026·2026-06-24

    Medtronic O-arm O2 imaging systems may produce image artifacts

    Medtronic O-arm O2 Imaging Systems are being recalled because an anomaly in the detector panel firmware may cause image artifacts. 589 units are affected.

    Product
    Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2026·2026-06-24

    Medline nursing kits contain catheters failing applicable performance specifications

    Medline Nursing Kits, SKU EDUC1044, are being recalled because representative samples did not meet applicable catheter performance specifications. 730 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044
    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
  • HighNHTSA·26V401000·2026-06-24

    Airstream Recalls 2025-2027 Vehicles Due to Rooftop Fan Fire Risk

    Airstream is recalling 2025-2027 Interstate and 2026 Classic recreational vehicles because a rooftop ventilation fan component may overheat and cause a fire.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE, CLASSIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0594-2026·2026-06-24

    Aripiprazole 30mg bottle contained voriconazole 50mg tablets instead

    Aripiprazole Tablets USP 30 mg from Ajanta Pharma are being recalled after a bottle containing Voriconazole Tablets 50 mg was labelled and distributed as aripiprazole. 6,143 bottles affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2026·2026-06-24

    Inspire stimulation leads labeled with Use By dates beyond shelf life

    Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2026·2026-06-24

    Giraffe OmniBed incubator canopy fasteners can fall into patient compartment

    Giraffe OmniBed incubator-warmers, all models, are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 19,587 units affected.

    Product
    Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
    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 P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2495-2026·2026-06-24

    Medline urethroplasty kits contain catheters failing performance specifications

    Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2504-2026·2026-06-24

    Medline D and C and cardiovascular packs contain substandard catheters

    Medline D and C Packs and a custom cardiovascular pack are being recalled because representative samples did not meet applicable catheter performance specifications. 168 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2494-2026·2026-06-24

    Medline tonsil packs contain catheters failing performance specifications

    Medline Tonsil Pack Cath procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 384 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2501-2026·2026-06-24

    Medline labour delivery and vaginal kits contain substandard catheters

    Medline labour and delivery and vaginal procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 24,388 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIV
    Category
    Medical Device
    Distribution
    Distributed nationwide