State

Maine product recalls

20,307 recalls have nationwide distribution and so reach Maine. 0 additional recalls listed Maine specifically in their distribution scope.

About recalls in Maine

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Maine consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

12026–12050 of 20307

HighFDA (Devices)·Z-2325-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Failure
Medline is recalling 13,881 sterile procedural kits worldwide due to potential sterility failure in the ultrasound gel component. The affected kits are used in various medical insertion procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1041-2023·2023-08-09
FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data
Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2269-2023·2023-08-09
SPiN Xtend Instruments Recalled for Electromagnetic Sensor Tracking Malfunction
Olympus Corporation is recalling 144 units of SPiN Xtend 2.0mm OD instruments (Model INS-5450) due to electromagnetic sensor tracking malfunction that impairs navigation during endobronchial procedures and may cause procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5450
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0968-2023·2023-08-09
Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 2,914 bags of vancomycin IV medication nationwide due to lack of assurance of sterility caused by missing validation data for decontamination cycles.
Product
vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2260-2023·2023-08-09
Philips Incisive CT Scanner Mounting Box Poses Injury Risk
A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.
Product
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1059-2023·2023-08-09
Fentanyl IV Bags Recalled for Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 19,014 bags of fentanyl IV injection nationwide due to lack of validated sterilization processes, which could affect product sterility.
Product
fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1018-2023·2023-08-09
FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (High K) IV bags due to lack of sterility assurance from insufficient validation of decontamination processes.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1060-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.
Product
HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1027-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling 132 bags of Cardioplegia Solution (Lot 36-254403) nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0962-2023·2023-08-09
FDA Recalls Phenylephrine IV Bags Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling phenylephrine IV bags nationwide due to insufficient sterility assurance and lack of validation data for decontamination cycles used in manufacturing.
Product
phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0994-2023·2023-08-09
Neonatal TPN Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 68 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility and missing validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0415-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0988-2023·2023-08-09
Norepinephrine IV bags recalled for sterility validation deficiency
Central Admixture Pharmacy Services recalled 80 bags of norepinephrine IV solution due to lack of sterility assurance and insufficient validation data for decontamination cycles. Product was distributed nationwide.
Product
norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1044-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services Inc is recalling HYDROmorphone injectable syringes because sterilization cycles were not validated. The recall affects 2,717 units distributed nationwide.
Product
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1036-2023·2023-08-09
Cardioplegia IV Solution Recalled for Sterilization Validation Deficiency
Central Admixture Pharmacy Services is recalling 88 bags of Cardioplegia Solution (Lot 36-255943) due to lack of assurance of sterility and insufficient validation of decontamination cycles. The product is used during cardiac surgery.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0961-2023·2023-08-09
Phenylepherine IV bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling over 8,300 phenylepherine IV bags nationwide because sterilization procedures were not adequately validated. Sterility cannot be assured for the affected units.
Product
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0969-2023·2023-08-09
Vancomycin IV bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 6,782 bags of vancomycin IV bags distributed nationwide due to lack of validation data for decontamination cycles, which compromises sterility assurance.
Product
vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0953-2023·2023-08-09
IV Medication Recall: dilTIAZem Bags Lack Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,699 bags of dilTIAZem IV medication due to lack of assurance of sterility and missing validation data for decontamination cycles. The affected medication was distributed nationwide.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1025-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1072-2023·2023-08-09
Fentanyl-bupivacaine injectable drug recalled due to sterility concerns
Central Admixture Pharmacy Services is recalling 896 bags of fentanyl-bupivacaine injectable solution nationwide due to lack of sterility assurance. The FDA Class II recall affects compounded pain medication lacking adequate sterilization validation.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0983-2023·2023-08-09
FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 463 bags of oxytocin IV solution nationwide due to inadequate validation data for sterilization processes. The product may not meet FDA sterility standards required for injectable medications.
Product
oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1054-2023·2023-08-09
Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling approximately 2,082 fentanyl injectable syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2291-2023·2023-08-09
Medline Anesthesia Procedural Kits Recalled for Potential Sterility Failure
Medline Industries recalls 1,130 anesthesia procedural kits over concerns that the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide including the US from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1070-2023·2023-08-09
Fentanyl and Bupivacaine Injectable Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 1,114 bags of fentanyl and bupivacaine injectable due to lack of validation data for sterilization. The product was distributed nationwide.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1008-2023·2023-08-09
Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 124 neonatal TPN starter bags nationwide due to lack of sterility assurance from missing decontamination validation data.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2301-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failure
Medline is recalling 41,123 procedural kits containing ultrasound gel that may fail to meet sterility specifications. The kits were distributed to healthcare facilities worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYN
Category
Medical Device
Distribution
Distributed nationwide