State

Maine product recalls

72,971 recalls have nationwide distribution and so reach Maine. 3,894 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total: 3,894
Critical: 468
Severe: 791
Most recent: 2026-09-02

Of the 3,894 recalls naming Maine we have scored against our rubric, 468 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 791 (20%) are Severe.

Which agencies issued them

These figures cover only the 3,894 recalls whose distribution notice names Maine specifically. The 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5501–5525 of 76865

ModerateFDA (Devices)·Z-2421-2025·2025-09-03
Dental implant locating kits recalled over thread defect limiting full engagement
Atlantis IO FLO-S Kits are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 102 units are affected.
Product
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2419-2025·2025-09-03
Light therapy devices recalled over welded nut that may shear off
Two NovoTHOR Gen 3.0 Reg PRX units are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.
Product
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2473-2025·2025-09-03
Coagulation analyzers recalled over potential reagent contamination in anti-Xa testing
STA Satellite analyzers are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 3,650 units are affected.
Product
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2422-2025·2025-09-03
Atlantis IO FLO-S kits recalled over thread defect limiting implant engagement
Atlantis IO FLO-S Kits, catalog A04S / 68020034, are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 780 units are affected.
Product
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring che
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2416-2025·2025-09-03
NovoTHOR light therapy devices recalled over welded nut that may shear
NovoTHOR devices, model S2188, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 80 units are affected.
Product
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature fo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2474-2025·2025-09-03
Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination
STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.
Product
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0596-2025·2025-09-03
Acetaminophen injection containers recalled after discoloration found in one lot
Baxter Acetaminophen Injection 1000 mg/100 mL in Viaflo containers, lot 24A27G66, is recalled nationwide because of discoloration. 13,000 containers are affected.
Product
ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2477-2025·2025-09-03
Medication dispensing stations recalled because antivirus software was not consistently installed
BD Pyxis MedStation and Anesthesia Station devices are recalled because antivirus software was not consistently installed during implementation. 8,353 devices are affected, 6,738 of them in the US.
Product
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2476-2025·2025-09-03
Fibrinogen test kits recalled over potential cross-contamination in heparin assays
STA-Fibrinogen 5 kits are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in heparin applications. 829,800 units are affected, 245,200 of them in the US.
Product
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2413-2025·2025-09-03
X8-2t ultrasound probes recalled for labelling defining device useful life
X8-2t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
X8-2t Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2402-2025·2025-09-03
L12-5 transducer probe serial B1D3VM recalled over useful life labelling
The L12-5 Transducer Probe is the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
TRANSDUCER L12-5 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2412-2025·2025-09-03
X7-2t transducer probes recalled to add useful life labelling information
X7-2t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
X7-2t Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2397-2025·2025-09-03
S8-3 ultrasound probes recalled to add field useful life labelling
S8-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
S8-3 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2406-2025·2025-09-03
X11-4t transducer probes recalled to add useful life labelling
X11-4t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
X11-4t Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2384-2025·2025-09-03
mC7-2 transducer probes recalled over useful life labelling clarification
mC7-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
mC7-2 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2362-2025·2025-09-03
C9-3v transducer probes recalled over useful life labelling clarification
C9-3v Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
C9-3v Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2391-2025·2025-09-03
S4-1 transducer probes recalled for useful life labelling in the field
S4-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
S4-1 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2388-2025·2025-09-03
OMNI III TEE transducer probes recalled to add useful life labelling
OMNI III TEE Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
OMNI III TEE Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2394-2025·2025-09-03
S5-2 transducer probes recalled to add useful life labelling
S5-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
S5-2 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2411-2025·2025-09-03
X7-2 transducer probes recalled over useful life labelling clarification
X7-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
X7-2 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2398-2025·2025-09-03
S8-3t ultrasound probes recalled for labelling defining device useful life
S8-3t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
S8-3t Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2387-2025·2025-09-03
OMNI II TEE transducer probes recalled over useful life labelling clarification
OMNI II TEE Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
OMNI II TEE Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2352-2025·2025-09-03
c5-1 transducer probes recalled for useful life labelling in the field
c5-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
c5-1 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2404-2025·2025-09-03
V9-2 transducer probes recalled to add useful life labelling
V9-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
V9-2 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2349-2025·2025-09-03
BP10-5ec ultrasound probes recalled for labelling defining device useful life
BP10-5ec Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
BP10-5ec Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide