State

Massachusetts product recalls

73,100 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 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

10251–10275 of 81339

HighFDA (Devices)·Z-3067-2024·2024-09-18
Dental Composite Resin Recall Due to Red Particulate Contamination
Ultradent Products recalls Transcend Econo Kit dental composite due to red particulates in the material from a manufacturing issue. Affected lot C1464 was distributed to dental professionals in 34 U.S. states and internationally.
Product
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indir
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-3068-2024·2024-09-18
FDA Recalls Transcend Dental Composite Material Due to Manufacturing Defect
Ultradent Products is recalling Transcend Singles Universal Body dental composite resin due to red particulates found during manufacturing. The recall affects approximately 2,450 units distributed in the US and several foreign countries.
Product
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for d
Category
Medical Device
Distribution
35 states
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-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-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-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-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-3062-2024·2024-09-18
Guidewire for Hemodialysis Catheters Recalled Due to Incorrect Assembly
Bard is recalling Guidewire 70cm x 1mm (REF 5583705) for hemodialysis catheters due to incorrect assembly. The stiff end may be positioned at the wrong location, risking injury during insertion into a patient.
Product
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
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-3077-2024·2024-09-18
SOL-M Syringes with eccentric tips recalled for regulatory non-compliance
Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.
Product
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3074-2024·2024-09-18
Syringes with Needles Recalled for Substantial Design Differences from FDA Approval
Sol-Millennium Medical Inc. is recalling multiple syringe models found to differ substantially from their FDA-cleared designs. The recalled products include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN branded syringes distributed in the United States and internationally.
Product
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe
Category
Medical Device
Distribution
Distributed nationwide
ModerateNHTSA·24T010000·2024-09-18
Goodyear Recalls Hercules Tires for Missing Identification Markings
Goodyear is recalling specific Hercules Terra Trac AT X-Venture tires because they lack the required week and year code on the tire identification number.
Product
TIRES:MARKINGS recall
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3112-2024·2024-09-18
Medline Suction Liners Recalled Due to Potential Loss of Suction
Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3132-2024·2024-09-18
Zimmer GmbH Recalls Mislabeled Biolox Option Taper Sleeve for Hip Replacement
Zimmer GmbH is recalling 69 units of Biolox Option Taper Sleeves due to incorrect packaging labels. The outer box may identify the wrong neck size, potentially leading to the use of the wrong device.
Product
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3129-2024·2024-09-18
Medical Action Industries Recalls Foam Protective Pouches Due to Labeling Error
Medical Action Industries is recalling foam protective pouches because they were improperly labeled with incorrect GMDN codes, leading to product misuse.
Product
Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3066-2024·2024-09-18
Ultradent Recalls Vit-l-escence Composite Due to Red Particulates
Ultradent is recalling Vit-l-escence Singles A3 composite restorative material because a manufacturing issue resulted in red particulates being present in the expressed composite.
Product
Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% fi
Category
Medical Device
Distribution
34 states
ModerateFDA (Drugs)·D-0658-2024·2024-09-18
Fluoride Dental Product Recalled Due to Label Mix-Up
Just Right 5000 fluoride dental product is being recalled due to a label mix-up affecting 120 direct customers nationwide.
Product
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3120-2024·2024-09-18
Medline recalls surgical convenience kits in Class II recall
Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3073-2024·2024-09-18
Medtronic InterStim Handset May Fail to Pair with Communicator
Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.
Product
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3095-2024·2024-09-18
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears Recalled for Packaging Seal
Medline is recalling 46 units of reprocessed Ethicon Harmonic ACE+7 Shears due to a potential incomplete seal on the packaging tray.
Product
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3079-2024·2024-09-18
FDA Recalls Syringe Tip Caps Due to Unapproved Device Modifications
Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.
Product
Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3103-2024·2024-09-18
Diagnostic test shows measurement bias at critical threshold
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.
Product
ADVIA Centaur CA 19-9 (50 Test)-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: 10491379 SMN: 11206239
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3094-2024·2024-09-18
Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect
Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.
Product
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V693000·2024-09-17
2024 Kia EV9 Remote Smart Parking Assist Software Error Recall
Kia is recalling certain 2024 EV9 vehicles because a software error in the remote smart parking assist feature may miscalculate stopping distances, increasing crash risk.
Product
KIA — KIA EV9
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V672000·2024-09-16
2024 Harley-Davidson Motorcycles Recalled for Electrical Short Circuit Risk
Harley-Davidson is recalling certain 2024 motorcycles because the voltage regulator output wire may rub on the crankcase, causing an electrical short circuit. This could result in loss of electrical and drive power while riding, increasing crash risk.
Product
HARLEY-DAVIDSON — HARLEY-DAVIDSON FLHX, FLTRX, FLTRXSE, FLHXSE
Category
Vehicle
Distribution
Distributed nationwide