State

Massachusetts product recalls

72,992 recalls have nationwide distribution and so reach Massachusetts. 8,211 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total: 8,211
Critical: 1,171
Severe: 2,013
Most recent: 2026-09-16

Of the 8,211 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 8,211 recalls whose distribution notice names Massachusetts specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8276–8300 of 81203

HighFDA (Devices)·Z-1067-2025·2025-02-05
Implantable VNS Therapy Generators May Stop Delivering Treatment
LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.
Product
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1023-2025·2025-02-05
CyberKnife Treatment System: Internal Snap Ring Detachment Risk
Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.
Product
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2025·2025-02-05
Karl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.
Product
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2025·2025-02-05
Medline procedure kits recalled for surgical masks failing sterilization tests
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
Product
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2025·2025-02-05
HOT AXIOS Stent Delivery System Outer Sheath May Detach, Preventing Stent Expansion
Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1035-2025·2025-02-05
Stent system outer sheath may detach, preventing proper expansion
Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and requiring device exchange.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2025·2025-02-05
AXIOS Stent Delivery System Outer Sheath May Detach During Use
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2025·2025-02-05
HemosIL Heparin Calibrators Recalled Over Quality Control Test Failures
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Product
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2025·2025-02-05
AXIOS Stent and Delivery System Recalled for Improper Expansion Risk
The AXIOS Stent and Delivery System is being recalled because the outer sheath can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Product
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2025·2025-02-05
Medical stent delivery system outer sheath component detachment prevents proper expansion
The HOT AXIOS Stent delivery system's outer sheath tip may detach during use, preventing proper stent expansion and requiring device exchange. Boston Scientific is recalling 1,102 units distributed nationwide.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2025·2025-02-05
Knee Implant Component Recalled for Incorrect Metal Post Assembly
Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2025·2025-02-05
Karl Storz Pediatric Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.
Product
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1062-2025·2025-02-05
Karl Storz Ureteroscope Model 27001K Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.
Product
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2025·2025-02-05
Medtronic Percutaneous Reference Pins May Not Fit Properly
Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.
Product
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a pat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1050-2025·2025-02-05
BD Pyxis MedStation Door Latch Assembly Failures in Automated Dispensing Cabinets
The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.
Product
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized he
Category
Medical Device
Distribution
54 states
HighFDA (Devices)·Z-1054-2025·2025-02-05
Karl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1032-2025·2025-02-05
Outer Sheath Detachment in HOT AXIOS Stent Delivery System
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0212-2025·2025-02-05
Duloxetine Delayed-Release Capsules recalled nationwide for nitrosamine impurity
Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.
Product
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1058-2025·2025-02-05
Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.
Product
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2025·2025-02-05
AXIOS Stent Delivery System: Detaching Outer Sheath May Prevent Stent Expansion
Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2025·2025-02-05
Karl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.
Product
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1037-2025·2025-02-05
HOT AXIOS Stent System Recalled Due to Outer Sheath Detachment Risk
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2025·2025-02-05
Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure
Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.
Product
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1034-2025·2025-02-05
Boston Scientific HOT AXIOS Stent Delivery Systems Recalled for Component Detachment
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1055-2025·2025-02-05
Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide