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.

9976–10000 of 81335

SevereFDA (Devices)·Z-3153-2024·2024-10-02
Ivenix Infusion Pump Software Recalled for Potential Malfunctions
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
Product
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3292-2024·2024-10-02
Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 units distributed worldwide.
Product
AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·24V750000·2024-10-02
School buses recalled for brake caliper mounting bolt defect
Navistar is recalling 2024-2025 IC Bus school buses because brake caliper mounting bolts may not be properly tightened, allowing the brake caliper to detach and cause loss of braking ability. Owner notification was sent in November 2024.
Product
IC BUS — IC BUS CESB, EVSB
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·24V738000·2024-10-02
GM Recalls 2024-2025 Chevrolet Silverado HD Trucks for Inactive Air Bags
General Motors is recalling certain 2024-2025 Chevrolet Silverado HD trucks because the air bag module may not have been activated, preventing deployment in a crash.
Product
CHEVROLET — CHEVROLET SILVERADO 5500, SILVERADO 6500, SILVERADO 4500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·24V739000·2024-10-02
2024 BMW i7 M70 Integrated Brake Module Malfunction Affects Stopping and Control
BMW is recalling certain 2024 i7 M70 and related models because the integrated brake module may malfunction, potentially reducing braking power and vehicle control. Dealers will replace the module at no cost.
Product
BMW — BMW 760I XDRIVE, 740I, 530I XDRIVE, I5 EDRIVE40
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3243-2024·2024-10-02
Medical device kit recalled due to inability to confirm sterilization assurance
American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.
Product
Cysto, FTCY03L; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3299-2024·2024-10-02
Arrow Arterial Kits Recalled Due to Open Packaging Seals
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.
Product
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3252-2024·2024-10-02
Biodesign Fistula Plug recalled for expiring before printed expiration date
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
Product
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3215-2024·2024-10-02
Siemens ACUSON Juniper ultrasound systems software unit conversion error
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
Product
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Category
Medical Device
Distribution
42 states
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-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-3280-2024·2024-10-02
FDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems (516 units) due to potential for delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-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 f
Category
Medical Device
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 (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 (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-3274-2024·2024-10-02
WallFlex Esophageal Stent System Recalled Due to Catheter Tip Detachment Risk
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.
Product
WALLFLEX FC ESO STENT RMV LL 23X155- 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 esop
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3223-2024·2024-10-02
Karl Storz Hopkins Telescope 6 Endoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3212-2024·2024-10-02
Cervical disc replacement recalled for foreign contamination in assembly
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
Product
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3218-2024·2024-10-02
Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3246-2024·2024-10-02
BD Phoenix M50 may misidentify E. coli bacteria in clinical samples
The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.
Product
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number:
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-3249-2024·2024-10-02
IntelliVue Patient Monitors recalled for electrical grounding defect
Philips is recalling approximately 545 IntelliVue Patient Monitor units with a broken ground bolt that may cause loss of electrical grounding, potentially affecting the device's electromagnetic immunity and emission.
Product
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3251-2024·2024-10-02
Cook Biotech Fistula Plug recalled for expiring before labeled date
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
Product
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
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-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