State

Maine product recalls

72,969 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 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4851–4875 of 76863

HighFDA (Devices)·Z-0203-2026·2025-10-22
Paclitaxel infusion sets recalled from one lot because IV sets may leak
Baxter is recalling 27,072 CLEARLINK System Paclitaxel Sets from one lot because the IV sets may leak.
Product
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2026·2025-10-22
Non-vented IV solution sets recalled from one lot because sets may leak
Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0198-2026·2025-10-22
Fourteen inch extension sets recalled from one lot because sets may leak
Baxter is recalling 2,304 CLEARLINK System straight-type extension sets with a retractable collar from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0180-2026·2025-10-22
Angiography procedure packs recalled after being sterilized more than once
American Contract Systems is recalling angiography and coronary convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0144-2026·2025-10-22
LGX preconnect pumps recalled over inflation and deflation performance issues
Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0174-2026·2025-10-22
Cystoscopy procedure packs recalled after being sterilized more than once
American Contract Systems is recalling cysto convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0193-2026·2025-10-22
Retractable collar solution sets recalled across many lots because sets may leak
Baxter is recalling 958,351 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0141-2026·2025-10-22
LGX preconnect pumps without InhibiZone recalled over inflation deflation issues
Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2026·2025-10-22
Biopsy and laparoscopy packs recalled after being sterilized more than once
American Contract Systems is recalling biopsy and laparoscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0172-2026·2025-10-22
General and laparotomy packs recalled after being sterilized more than once
American Contract Systems is recalling general, chest, laparotomy and interventional radiology convenience packs that were re-gassed after a sterilization nonconformance.
Product
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2026·2025-10-22
Forty four inch extension sets recalled because the IV sets may leak
Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0131-2026·2025-10-22
Carotid stent systems recalled because integrated filter may not fully open
Contego Medical is recalling 568 Neuroguard IEP carotid stent systems because the integrated filter may not open, or may not fully open, during sheath retraction and filter knob operation.
Product
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2026·2025-10-22
Ultrasound systems recalled over inaccurate liver steatosis measurement values
GE is recalling 65 LOGIQ P10 series systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Product
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2026·2025-10-22
Humidifier devices recalled because power loss alert sounds under two minutes
Fisher & Paykel is recalling 51,144 Airvo 2 and myAirvo 2 humidifiers because an unintentional power disconnection may sound an audible alert for less than 120 seconds.
Product
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0186-2026·2025-10-22
PICC and gastrostomy tube packs recalled after being sterilized more than once
American Contract Systems is recalling PICC G-Tube convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0194-2026·2025-10-22
Three valve retractable collar sets recalled across many lots for leak potential
Baxter is recalling 1,167,120 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0179-2026·2025-10-22
Gynecology procedure packs recalled after being sterilized more than once
American Contract Systems is recalling gynecology, laparoscopy and hysteroscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0138-2026·2025-10-22
TENACIO pumps with InhibiZone recalled over inflation and deflation issues
Boston Scientific is recalling 59 TENACIO Pump with InhibiZone units, UPN 72404429, because of the potential for inflation or deflation performance issues or difficulties.
Product
TENACIO Pump with InhibiZone; UPN: 72404429;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2026·2025-10-22
LOGIQ P10 HD systems recalled over inaccurate liver steatosis measurement values
GE is recalling 31 LOGIQ P10 R4.5 HD ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Product
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0157-2026·2025-10-22
LOGIQ P9 ultrasound systems recalled over inaccurate liver steatosis measurements
GE is recalling 37 LOGIQ P9 R4.5 ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Product
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0181-2026·2025-10-22
Caesarean section packs recalled after being sterilized more than once
American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2026·2025-10-22
Basic biopsy trays recalled after entire lot was sterilized more than once
American Contract Systems is recalling a Basic Biopsy Tray lot that was re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Basic Biopsy Tray, Item Number NMBP44L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0185-2026·2025-10-22
Eye and cataract packs recalled after being sterilized more than once
American Contract Systems is recalling cataract, eye, retinal and vitrectomy convenience packs that were re-gassed after a sterilization nonconformance.
Product
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2026·2025-10-22
Wound dressings recalled because foreign matter may be on the product
ConvaTec is recalling 80,980 DuoDERM Extra Thin dressings from one lot because the wound dressing may have foreign matter on the product.
Product
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM"
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0199-2026·2025-10-22
Extension IV sets recalled from one lot because the sets may leak
Baxter is recalling 16,416 CLEARLINK System straight-type extension sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
Category
Medical Device
Distribution
Distributed nationwide