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.

12001–12025 of 20307

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-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 (Devices)·Z-2329-2023·2023-08-09
Ultrasound Gel in Medline Procedural Kits Recalled Over Sterility Specification Concerns
Medline Industries recalled approximately 154,900 Custom Sterile and Non-Sterile Procedural Kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: DYNDA1219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0948-2023·2023-08-09
Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.
Product
vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
Category
Drug
Distribution
Distributed nationwide
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-1046-2023·2023-08-09
FDA Recalls Fentanyl Syringes for Sterility Assurance Failure
Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. The product was distributed nationwide.
Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
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-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-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 (Devices)·Z-2317-2023·2023-08-09
Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect
Medline Industries recalled 11,436 procedural kits with Turkuaz ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1047-2023·2023-08-09
Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 1,216 fentanyl 2500 mcg/50 mL syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure sterility.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1056-2023·2023-08-09
Succinylcholine Injectable Syringes Recalled for Sterility Validation Deficiency
Central Admixture Pharmacy Services Inc recalls 12,239 succinylcholine injection syringes (200 mg/10 mL) distributed nationwide due to lack of validation data for sanitization cycles.
Product
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2333-2023·2023-08-09
Medline Surgical Procedural Kits Recalled Due to Sterility Concerns
Medline Industries is recalling approximately 7,462 custom surgical procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall affects kits distributed worldwide since April 2020.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1028-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 196 bags of cardioplegia solution nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2285-2023·2023-08-09
STATCLAVE G4 Medical Sterilizer Recalled for Incomplete Sterilization Risk
FDA recalls 19 units of the STATCLAVE G4 steam sterilizer (Class II). The device may result in incomplete sterilization when used with incompatible materials.
Product
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2334-2023·2023-08-09
Medline sterile procedural kits recalled for potential sterility specification failures
Medline is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The kits were distributed worldwide to hospitals and medical facilities.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1042-2023·2023-08-09
FDA Recalls Fentanyl Injections Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,197 syringes of fentanyl injectable solution due to lack of validation for sterilization cycles. The product was distributed nationwide.
Product
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2326-2023·2023-08-09
FDA Recalls Medline Procedural Kits Due to Potential Sterility Failure
Medline Industries is recalling 22 procedural kits because the included ultrasound gel may not be sterile as labeled. The kits were distributed worldwide.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2023·2023-08-09
Medline Procedural Kits Recalled Due to Sterility Specification Failure
Medline Industries recalls 15,945 Custom Sterile and Non-Sterile Procedural Kits due to potential failure of the Turkuaz ultrasound gel component to meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1078-2023·2023-08-09
Phenylephrine Injection Syringes Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine injection due to lack of validation data for sterilization processes. The product was distributed nationwide.
Product
PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
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-1063-2023·2023-08-09
Fentanyl Injectable Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 1,044 bags of fentanyl injectable solution due to lack of validated sanitization procedures that could compromise sterility assurance. The product affects healthcare facilities nationwide.
Product
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
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 (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-1014-2023·2023-08-09
Neonatal TPN Starter Bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 80 Neonatal TPN Starter Bags due to lack of sterile assurance. Decontamination cycle validation data was not available, creating a potential contamination risk.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/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: 72196-0423-1
Category
Drug
Distribution
Distributed nationwide