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.

12126–12150 of 20305

HighFDA (Devices)·Z-2328-2023·2023-08-09
Medline Procedural Kit Ultrasound Gel Sterility Specification Failure
Medline Industries is recalling procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed to healthcare facilities worldwide from 2020 to 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B
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-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-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-0950-2023·2023-08-09
Vancomycin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,824 bags of vancomycin IV medication nationwide due to inadequate validation of sterilization processes. The manufacturer cannot confirm proper sterility.
Product
vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
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-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-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-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 (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-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-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 (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 (Devices)·Z-2293-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Failure
Medline has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits 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.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1050-2023·2023-08-09
Fentanyl Injectable Solution Recalled for Unvalidated Sterilization Cycles
Central Admixture Pharmacy Services is recalling 848 bags of fentanyl injection nationwide due to lack of validated sterilization processes that assure product sterility. Multiple lots distributed to healthcare facilities are affected.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1073-2023·2023-08-09
ePHEDrine Injectable Syringes Recalled Over Sterility Assurance Gaps
Central Admixture Pharmacy Services is recalling 8,942 ePHEDrine syringes nationwide due to lack of validation data for sterilization procedures, creating a potential sterility risk for injectable medications.
Product
ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2271-2023·2023-08-09
Chest Stabilization Device Latch May Fail During Cardiac Surgery
The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.
Product
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1064-2023·2023-08-09
Morphine Syringes Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 1,699 morphine syringes nationwide due to lack of validated sanitization cycles, which may compromise sterility assurance.
Product
morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0974-2023·2023-08-09
Heparin IV Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling heparin IV bags due to lack of sterility assurance and missing validation data for decontamination cycles. The recall affects 358 bags distributed nationwide.
Product
heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8000-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0973-2023·2023-08-09
FDA Recalls Oxytocin Injectable Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,821 bags of oxytocin IV bags nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2308-2023·2023-08-09
Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards
Medline is recalling 1,130 custom sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Specification Failure
Medline has recalled 63,823 custom procedural kits due to potential sterility specification failure of the ultrasound gel component. The affected kits were distributed worldwide from April 2020 through April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1005-2023·2023-08-09
Neonatal TPN IV Bags Recalled Over Sterility Assurance Failures
Central Admixture Pharmacy Services is recalling 304 neonatal TPN IV starter bags nationwide due to lack of sterility assurance and insufficient validation of decontamination processes. No illnesses have been reported.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/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: 72196-0429-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0981-2023·2023-08-09
Heparin intravenous bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.
Product
heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2247-2023·2023-08-09
VERITAS Advanced Infusion and Fluidics Packs Recalled for Weld Defect
Johnson & Johnson is recalling 148,941 VERITAS Advanced Infusion and Fluidics surgical packs due to weld defects that could cause vacuum failure during surgery, potentially leading to surgical delays and temporary eye swelling.
Product
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Category
Medical Device
Distribution
Distributed nationwide