State

Maine product recalls

73,092 recalls have nationwide distribution and so reach Maine. 3,922 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total: 3,922
Critical: 478
Severe: 803
Most recent: 2026-09-23

Of the 3,922 recalls naming Maine we have scored against our rubric, 478 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 803 (20%) are Severe.

Which agencies issued them

These figures cover only the 3,922 recalls whose distribution notice names Maine specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8076–8100 of 77014

HighFDA (Devices)·Z-1021-2025·2025-02-05
Design Options Combined Spinal/Epidural Tray Recalled for Connector Defect
B. Braun Medical is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray due to an incorrect catheter connector that cannot securely connect to the epidural catheter, preventing medication administration.
Product
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
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-1057-2025·2025-02-05
Karl Storz Uretero-Renoscope with Unapproved Reprocessing Instructions Recalled
Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1051-2025·2025-02-05
Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling a uretero-renoscope surgical device (REF 27003L) because the reprocessing instructions in the product documentation have not been reviewed or approved by the FDA.
Product
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
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-1065-2025·2025-02-05
Alphatec Calibrate CCX Interbody Implants Recalled for Post-Operative Collapse
Alphatec Spine is recalling Calibrate CCX spinal implants used in fusion procedures after receiving complaints of post-operative implant collapse. Approximately 1,511 implants were distributed nationwide.
Product
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 d
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-1056-2025·2025-02-05
Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
Product
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
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
HighNHTSA·25V056000·2025-02-05
2025 Honda Pilot third-row seat belt may not restrain occupant
Honda is recalling certain 2025 Pilot vehicles because the third-row passenger seat belt may not function due to incorrect routing. A non-functioning seat belt cannot properly restrain occupants, increasing injury risk during a crash.
Product
HONDA — HONDA PILOT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2025·2025-02-05
AXIOS Stent Delivery System recalled due to distal sheath detachment
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
Product
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2025·2025-02-05
Bedside cardiac monitor system recalled for display distortion
The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.
Product
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
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-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
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-1066-2025·2025-02-05
Infinity Central Station speakers may fail to produce critical patient alarms
Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.
Product
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of dat
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-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-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-1026-2025·2025-02-05
AXIOS stent delivery system outer sheath detachment prevents proper expansion
Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
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
ModerateFDA (Devices)·Z-1042-2025·2025-02-05
Medline procedure kits recalled for surgical mask bioburden contamination risk
Medline procedure kits containing surgical masks are recalled nationwide because included masks failed to meet bioburden testing standards, creating potential infection risk during medical procedures.
Product
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1063-2025·2025-02-05
Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.
Product
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0209-2025·2025-02-05
Badger 50 Mineral Sunscreen Recalled for Missing Drug Facts Labeling
The W.S. Badger Company is recalling Badger 50 mineral sunscreen tins lacking the complete drug facts label, barcode, and directions for use. The recall affects 4,834 tins distributed nationwide.
Product
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
Category
Drug
Distribution
Distributed nationwide