State

Pennsylvania product recalls

20,305 recalls have nationwide distribution and so reach Pennsylvania. 0 additional recalls listed Pennsylvania specifically in their distribution scope.

About recalls in Pennsylvania

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 Pennsylvania 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.

12151–12175 of 20305

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-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-0980-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Concerns
Central Admixture Pharmacy Services recalled 52 neonatal TPN starter bags nationwide due to lack of validation data for sterilization processes, raising concerns about sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, IV Bag, Total Volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0430-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0993-2023·2023-08-09
Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Defect
Central Admixture Pharmacy Services is recalling 188 neonatal TPN bags nationwide because sterility assurance cannot be guaranteed. Validation data for decontamination cycles is lacking.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0416-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1000-2023·2023-08-09
Neonatal TPN Bags Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 516 Neonatal TPN Starter Bags due to insufficient validation of decontamination processes. The recall affects bags distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/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: 72196-0420-1
Category
Drug
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-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 (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-1031-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (100 mEq K) due to inadequate validation of decontamination processes. The recall affects 284 units distributed nationwide. Affected facilities should discontinue use and contact the manufacturer.
Product
CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2319-2023·2023-08-09
Medline sterile procedural kits recalled for potentially non-sterile gel
Medline is recalling 83,541 procedural kits because the included ultrasound gel component may not meet required sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1071-2023·2023-08-09
Ketamine Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 2,994 syringes of ketamine injection distributed nationwide due to lack of validated sterilization procedures that ensure product sterility.
Product
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2313-2023·2023-08-09
Sterile Procedural Kits Recalled Due to Potential Ultrasound Gel Sterility Failure
Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel because the gel component may not meet sterility specifications. The kits are distributed worldwide for dialysis procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
Category
Medical Device
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-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-1079-2023·2023-08-09
Fentanyl Injectable Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling approximately 6,770 fentanyl syringes distributed nationwide due to lack of validated sanitization data. The injectable medication may not have proper sterility assurance.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1051-2023·2023-08-09
Fentanyl Injectable Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl injections because sterilization procedures were not properly validated, raising infection risks from potential contamination.
Product
fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1009-2023·2023-08-09
Neonatal TPN starter bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 244 neonatal TPN IV bags due to lack of assurance that the sterility process was validated. The manufacturer lacked adequate validation data for their decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2321-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure
Medline is recalling 233,638 procedural kits containing Turkuaz ultrasound gel that may not meet sterility specifications. The potentially non-sterile gel could pose infection risks during medical procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2258-2023·2023-08-09
Philips CT scanner heat exchanger box may detach and cause injury
The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.
Product
Incisive CT-Computed Tomography X-Ray System Model: 728143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1001-2023·2023-08-09
FDA Recalls Neonatal TPN Starter Bag for Lacking Sterility Assurance
Central Admixture Pharmacy Services recalls 68 neonatal TPN starter bags nationwide due to lack of validation data for decontamination cycles, posing a contamination risk.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0427-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1068-2023·2023-08-09
Morphine Injection Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling morphine injections nationwide due to inadequate validation of sterilization procedures, which poses a potential sterility risk.
Product
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2255-2023·2023-08-09
NeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk
NeuMoDx Molecular Inc is recalling 20,016 cartridges from three lots due to incorrect label placement during manufacturing. Misplaced labels may interfere with optical performance, increasing risk for false positive test results.
Product
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2023·2023-08-09
OEC 9900 Systems Image Intensifier Detachment and Fall Risk
GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.
Product
OEC 9900 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2023·2023-08-09
X-ray therapy system carriage bolts may loosen and suspension rail crack
Philips Azurion 7 M20 X-ray imaging systems may have loose or broken carriage support bolts and cracks in the suspension rail. The Class II recall affects 648 units distributed worldwide.
Product
Azurion 7 M20. X-ray Image guided Therapy System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0955-2023·2023-08-09
Vancomycin IV Bags Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 15,304 bags of vancomycin IV solution due to lack of validation data confirming proper sterilization of the product.
Product
vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
Category
Drug
Distribution
Distributed nationwide