State

Maine product recalls

73,104 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 73,104 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9351–9375 of 77026

HighFDA (Devices)·Z-0179-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile packaging
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.
Product
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0084-2025·2024-10-30
Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled
Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.
Product
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Sterility Compromise
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.
Product
Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0167-2025·2024-10-30
Medline chest tube insertion tray may contain non-sterile equipment due to breached seal
Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.
Product
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2025·2024-10-30
Ultrasound Systems Recalled for Loose Power Connections Causing Thermal Hazard
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
Product
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile product risk
Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.
Product
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0173-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Non-Sterile Product Risk
Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0159-2025·2024-10-30
Medline dental pack may contain non-sterile product due to packaging defect
Medline dental procedure kits may contain non-sterile product if the breather pouch seal is compromised. The recall affects 165 units distributed in the US, Canada, and Panama.
Product
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0177-2025·2024-10-30
Medline Medical Procedure Convenience Kits Recalled for Sterility Risk
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow the use of non-sterile products if the vendor seal is opened.
Product
Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterile Product
Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.
Product
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0150-2025·2024-10-30
Medline Centurion Medical Procedure Kits Recalled for Sterility Risk
Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.
Product
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0223-2025·2024-10-30
A1CNow+ Multi-Test HbA1c System recalled due to mismatched cartridge and analyzer codes
Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.
Product
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0016-2025·2024-10-30
Phenylephrine Injection Recalled Due to Manufacturing Quality Violations
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0015-2025·2024-10-30
Sterile drug injection bags recalled for manufacturing process violations
Fresenius Kabi Compounding recalled 1,631 bags of Phenylephrine HCl injection due to manufacturing process violations. The product was distributed to 125 healthcare facilities nationwide. The recall was concluded in August 2025.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0181-2025·2024-10-30
Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming
Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.
Product
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0209-2025·2024-10-30
Blue Ortho Recalls Predict+ Software for Lack of FDA Clearance
Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.
Product
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0064-2025·2024-10-30
Horizon Organic Ultra Pasteurized Heavy Whipping Cream recalled for potential premature spoilage
Horizon Organic Dairy is recalling approximately 2,956 cases of Ultra Pasteurized Heavy Whipping Cream (BEST BY 10/22/24) distributed across 14 states due to the potential for premature spoilage during shelf life.
Product
Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) Broomfield, CO 80021.UPC: 742365216855
Category
Food
Distribution
14 states
ModerateFDA (Drugs)·D-0021-2025·2024-10-30
Oxytocin Injection Recalled for Current Good Manufacturing Practice Violations
Fresenius Kabi Compounding is voluntarily recalling over 4,400 bags of Oxytocin 0.9% Sodium Chloride Injection due to current Good Manufacturing Practice violations. No illnesses have been reported.
Product
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0018-2025·2024-10-30
Vancomycin Injection Recalled Due to Manufacturing Process Violations
Fresenius Kabi Compounding is recalling Vancomycin HCl injectable medication due to cGMP manufacturing violations. The recall affects 1,082 bags distributed to 125 healthcare accounts nationwide.
Product
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0166-2025·2024-10-30
Medline Medical Procedure Convenience Kits Class II Recall
Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.
Product
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0025-2025·2024-10-30
Stool Softener Laxative Recalled Due to Manufacturing Practice Deviations
Akron Pharma is recalling OneLAX Docusate Sodium Liquid stool softener due to manufacturing practice deviations. The recall affects 10,845 bottles distributed nationwide.
Product
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0138-2025·2024-10-30
Quantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling Quantimetrix Urine Chemistry Control Sets shipped without validated summer packaging, potentially exposing them to temperatures above 25°C.
Product
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0019-2025·2024-10-30
Drug Recall: NORepinephrine Injectable Due to Manufacturing Compliance Violations
Fresenius Kabi Compounding recalls 2,151 bags of NORepinephrine Bitartrate injectable due to manufacturing violations. The voluntary recall affects 125 healthcare accounts nationwide.
Product
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0207-2025·2024-10-30
Diasol Acid Concentrate Recalled for Labeling Discrepancy
Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate because the gallon label shows a lower calcium concentration than the box label.
Product
Diasol Acid Concentrate REF G100325-10Dex 100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0014-2025·2024-10-30
Drug injection product recalled due to manufacturing quality violations
Fresenius Kabi Compounding is recalling phenylephrine HCl injection bags due to manufacturing quality violations. The recall affects 1,313 bags distributed to 125 healthcare accounts.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Category
Drug
Distribution
Distributed nationwide