State

Massachusetts product recalls

73,096 recalls have nationwide distribution and so reach Massachusetts. 8,239 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total: 8,239
Critical: 1,181
Severe: 2,025
Most recent: 2026-09-23

Of the 8,239 recalls naming Massachusetts we have scored against our rubric, 1,181 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,025 (25%) are Severe.

Which agencies issued them

These figures cover only the 8,239 recalls whose distribution notice names Massachusetts specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

10051–10075 of 81335

HighFDA (Devices)·Z-3285-2024·2024-10-02
Esophageal Stent System Recalled Due to Potential Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3234-2024·2024-10-02
Medical Paracentesis Kit Recalled Over Sterilization Assurance Failure
504 paracentesis kits (Lot 2405102) are being recalled because the manufacturer cannot confirm that sterilization requirements were met during production.
Product
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0665-2024·2024-10-02
Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach
Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.
Product
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0660-2024·2024-10-02
Mupirocin Antibiotic Ointment Recalled Nationwide Due to Subpotency
Glenmark Pharmaceuticals recalls Mupirocin Ointment nationwide due to subpotency, meaning some lots contain less active ingredient than specified. Affected customers should contact their pharmacy or prescriber.
Product
MUPIROCIN — MUPIROCIN (MUPIROCIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3193-2024·2024-10-02
MRI Diagnostic Device Recalls Due to Loose Screw Assembly Risk
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Product
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0664-2024·2024-10-02
FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach
AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.
Product
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3282-2024·2024-10-02
Boston Scientific recalls WallFlex and Agile esophageal stents for delivery catheter detachment
Boston Scientific has recalled 308 units of WallFlex and Agile esophageal stent systems due to the potential for delivery catheter tip detachment during stent placement. The affected devices are distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3302-2024·2024-10-02
Cardinal Health Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
Product
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3235-2024·2024-10-02
IR Procedure Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems recalls IR Procedure Pack (Lot 2405102, expiration 05/10/2024) because it cannot confirm sterilization requirements were met. An inoperable chart recorder caused humidity levels to be out-of-specification.
Product
IR Procedure Pack, CEAT19W; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3279-2024·2024-10-02
Boston Scientific esophageal stent systems recalled for catheter tip detachment
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3265-2024·2024-10-02
Esophageal stent system recalled due to potential delivery catheter detachment
Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.
Product
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3248-2024·2024-10-02
Hologic Recalls Selenia Dimensions and 3Dimensions Breast Imaging Software
Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.
Product
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3221-2024·2024-10-02
Medical endoscope recalled for unapproved sterilization instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
Product
Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3259-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug units expire before labeled date
Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3198-2024·2024-10-02
Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
Product
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3206-2024·2024-10-02
BARD MAGNUM Biopsy Needles Recalled Due to Packaging Damage Risk
Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.
Product
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3238-2024·2024-10-02
Vaginal Delivery Medical Convenience Kit Recalled for Unconfirmed Sterilization Assurance
American Contract Systems, Inc. is recalling the Vaginal Delivery ASDV25B medical convenience kit due to an inoperable chart recorder that prevented confirmation of sterilization assurance. The device may not meet required sterilization standards.
Product
Vaginal Delivery, ASDV25B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3266-2024·2024-10-02
WallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
Product
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3209-2024·2024-10-02
Ultrasonic Cleaner Solution Recalled for Bacterial Contamination and Infection Risk
Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.
Product
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3244-2024·2024-10-02
Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Product
Pacemaker, COPM11B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1820-2024·2024-10-02
Montreal Fudge Chocolate Fudge with Nuts Recalled for Mold Contamination
Authentik Fudge is recalling Montreal Fudge brand Chocolate Fudge with Nuts due to potential mold contamination. The affected products were distributed through TJ Maxx and Marshalls locations.
Product
Montreal Fudge brand Chocolate Fudge with Nuts; 5.6oz
Category
Food
Distribution
40 states
HighFDA (Devices)·Z-3276-2024·2024-10-02
Boston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment
Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3194-2024·2024-10-02
Philips Ingenia 1.5T MRI Device Recall: Loose Screws May Block Tabletop
Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.
Product
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3187-2024·2024-10-02
Roche Creatine Kinase test reagents recalled for calibration errors
Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.
Product
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3240-2024·2024-10-02
Surgical convenience kit sterilization assurance cannot be confirmed
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
Product
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide