The Recall Desk

State

New York product recalls

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

About recalls in New York

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 New York 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.

12101–12125 of 20307

  • HighFDA (Devices)·Z-2332-2023·2023-08-09

    Medline Recalls Procedural Kits Over Sterility Specification Failure

    Medline Industries is recalling 9,319 procedural kits worldwide because the labeled sterile ultrasound gel component may not meet sterility specifications. The affected kits were distributed between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model N
    Category
    Medical Device
    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-2272-2023·2023-08-09

    Cardiac Surgery Device Blade May Fail to Latch Securely During Use

    The ACROBAT SUV blade may not latch securely onto its activator drive during use. This could prevent heart stabilization during surgery, cause positioning loss, or release device components into the patient.

    Product
    ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2023·2023-08-09

    Medline procedural kits recalled for ultrasound gel sterility defect

    Medline recalls 100,549 procedural kits because the sterile ultrasound gel component may not meet sterility specifications. No illnesses or injuries have been reported.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYN
    Category
    Medical Device
    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-2336-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Sterility Specification Concerns

    Medline Industries is recalling 211 custom procedural kits (egg retrieval, fetal surgery, TVT packs) worldwide because the sterile ultrasound gel component may not meet sterility specifications. Kits were distributed between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, Model Number: DYNJ66291B; b. FETAL SURGERY CDS-LF, Model Number: CDS840214P; c. TVT PACK SMGH-LF, Model Number: DYNJ41913C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1017-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of sterility assurance and missing decontamination validation data. The affected lot was distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0106-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2023·2023-08-09

    Medline Probe Cover Kits recalled for potential sterility specification failure

    Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.

    Product
    Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1034-2023·2023-08-09

    Cardioplegia IV Solution Recalled Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services has recalled Cardioplegia Solution due to lacking sterility assurance and insufficient validation data for decontamination cycles. The recall affects 148 bags distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0214-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2023·2023-08-09

    ACROBAT-i Vacuum Stabilizer Blade Latching Failure in Cardiac Surgery Systems

    A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.

    Product
    ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1021-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services recalls Cardioplegia Solution (Lot 36-253947) due to lack of sterility assurance and insufficient decontamination validation. Healthcare facilities should discontinue use and contact the manufacturer.

    Product
    CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1039-2023·2023-08-09

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot 36-254906) due to lack of assurance of sterility and missing validation data for decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2337-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Potential Sterility Specification Failures

    Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not 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. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
    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 (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 (Devices)·Z-2299-2023·2023-08-09

    Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect

    Medline Industries recalls 104,755 procedural kits due to potential sterility defect in ultrasound gel component. No illnesses or injuries have been reported.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel

    Medline Industries is recalling 7,040 custom sterile procedural kits containing ultrasound gel because the gel component may not meet sterility specifications, creating a potential infection risk.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1043-2023·2023-08-09

    Fentanyl injection syringes recalled for unvalidated sterilization process

    Central Admixture Pharmacy Services is recalling 5,124 fentanyl syringes because the manufacturer lacks validation that its sterilization process is effective. The nationwide recall affects multiple lot numbers distributed through September 2023.

    Product
    fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
    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-1074-2023·2023-08-09

    Lidocaine Injectable Syringes Recalled for Sterilization Assurance Concerns

    CAPS Inc. is recalling 9,517 lidocaine 2% injectable syringes distributed nationwide due to lack of sterilization validation data. No illnesses have been reported.

    Product
    lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
    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-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-1053-2023·2023-08-09

    FDA Recalls Fentanyl Syringes Due to Sterility Validation Concerns

    Central Admixture Pharmacy Services is recalling 1,669 fentanyl syringes nationwide due to lack of validation data for sanitization cycles, preventing assurance of product sterility.

    Product
    fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1016-2023·2023-08-09

    FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance

    The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.

    Product
    CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
    Category
    Drug
    Distribution
    Distributed nationwide