State

Massachusetts product recalls

72,936 recalls have nationwide distribution and so reach Massachusetts. 8,209 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total: 8,209
Critical: 1,171
Severe: 2,013
Most recent: 2026-09-09

Of the 8,209 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 2,013 (25%) are Severe.

Which agencies issued them

These figures cover only the 8,209 recalls whose distribution notice names Massachusetts specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3151–3175 of 81145

HighFDA (Devices)·Z-1386-2026·2026-02-25
Medline Convenience Kits and CPNB Setup Trays Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 779 units of convenience kits and setup trays due to potential sterility assurance issues from equipment calibration problems during manufacturing.
Product
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1390-2026·2026-02-25
Medline Cardiac Surgical Convenience Kits Recalled Due to Sterility Calibration Issues
Medline Industries is recalling cardiac surgical convenience kits due to sterilization equipment calibration issues that could affect device sterility assurance levels.
Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2026·2026-02-25
Da Vinci 5 Surgical System Console Recalled Due to Software Error
Intuitive Surgical, Inc. is recalling the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 due to a software error that can cause loss of user interface content on monitors.
Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1394-2026·2026-02-25
Cochlear and head kits recalled over sterilization equipment calibration issues
Medline is recalling 9,051 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1393-2026·2026-02-25
Medline Dental Packs Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling certain Medline Convenience Kits (Dental Pack, Model DYNDA3003) because equipment calibration issues may have impacted the sterility of the products.
Product
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2026·2026-02-25
Estrone RIA Diagnostic Kit Recall by Immunotech A.S.
Immunotech A.S. is recalling 160 Estrone RIA kits (REF: DSL8700) that may rarely give falsely high patient results, which could cause temporary injury with remote probability.
Product
Estrone RIA, REF: DSL8700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2026·2026-02-25
Cervical disc implants recalled after 5mm product was labeled 6mm
Centinel Spine is recalling 20 Prodisc C SK total cervical disc replacements because products were mislabeled as the 6mm product but included the 5mm product.
Product
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1399-2026·2026-02-25
Medline Medical Device Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 154,427 medical device convenience kits due to calibration issues with sterilization equipment that could affect sterility assurance levels. No illnesses or injuries have been reported.
Product
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC01054
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2026·2026-02-25
Arteriogram and catheter kits recalled over sterilization calibration issues
Medline is recalling 30,958 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1374-2026·2026-02-25
Olympus Thunderbeat 5 mm 45 cm Front-Actuated Grip Medical Device Recall
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 45 cm Front-Actuated Grip devices due to reports of adverse events.
Product
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2026·2026-02-25
Triple lumen insertion kits recalled over sterilization calibration issues
Medline is recalling 15 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1367-2026·2026-02-25
Catheter cutdown trays recalled over damage to the outer tray
Bard Peripheral Vascular is recalling 14,935 Broviac 4.2 Fr single-lumen CV catheter cutdown trays because damage to the outer tray can potentially compromise the sterile barrier.
Product
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1403-2026·2026-02-25
WMC ID packs recalled over sterilization equipment calibration issues
Medline is recalling 32 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2026·2026-02-25
GI endoscopy kits recalled over sterilization equipment calibration issues
Medline is recalling 23,238 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2026·2026-02-25
Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks
Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.
Product
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2026·2026-02-25
Thunderbeat pistol grip devices removed after continued adverse event reports
Olympus is removing the Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip from the market, stating the action is due to continued reports of adverse events.
Product
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2026·2026-02-25
Endoscopy and angiography kits recalled over sterilization calibration issues
Medline is recalling 3,561 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling certain Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26C002000·2026-02-25
Evenflo Recalls LiteMax Child Seats Due to Incorrect Spanish Manual
Evenflo is recalling LiteMax Factory Select child seats because the Spanish manual lists incorrect weight and height limits, which could lead to improper restraint.
Product
EQUIPMENT:OTHER:OWNERS/SERVICE/OTHER MANUAL recall
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2026·2026-02-25
Oncology and biopsy kits recalled over sterilization calibration issues
Medline is recalling 2,740 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1364-2026·2026-02-25
Medihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
Integra LifeSciences Corp. is recalling certain Medihoney Calcium Alginate dressings because packaging failures could lead to a breach in the sterile barrier.
Product
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2026·2026-02-25
Olympus Thunderbeat 5 mm 35 cm Surgical Device Recalled Due to Adverse Events
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Type S devices due to reports of adverse events.
Product
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2026·2026-02-25
Choice drape packs recalled over sterilization equipment calibration issues
Medline is recalling 72 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2026·2026-02-25
PPE kits recalled over sterilization equipment calibration issues
Medline is recalling 7,575 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2026·2026-02-25
LVAD driveline trays recalled over sterilization equipment calibration issues
Medline is recalling 9,720 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Category
Medical Device
Distribution
Distributed nationwide