The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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13276–13300 of 27722

  • HighFDA (Devices)·Z-1391-2024·2024-04-03

    Puritan HydroFlock Collection Device Distributed with Wrong Product Code

    Puritan Medical Products distributed HydroFlock Sterile Flocked Collection Devices labeled as Part Number 25-3317-H, Lot S1014 that actually contain product code 25-3317-U. Approximately 232,500 units were affected.

    Product
    HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0406-2024·2024-04-03

    HYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues

    SCA Pharmaceuticals is recalling 1,425 syringes of HYDROmorphone HCl 6 mg/30 mL due to lack of assurance of product sterility. The affected lots were distributed nationwide.

    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0405-2024·2024-04-03

    HYDROmorphone Injection Syringes Recalled for Sterility Assurance Issue

    SCA Pharmaceuticals is recalling HYDROmorphone HCl injection syringes due to lack of assurance of sterility. The recall affects 5,734 syringes distributed nationwide.

    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0400-2024·2024-04-03

    Fentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue

    SCA Pharmaceuticals recalls 412 cassettes of fentanyl-bupivacaine epidural injection (lots 1223049261 and 1223049724) due to lack of assurance of sterility.

    Product
    fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2024·2024-04-03

    Epix Universal Clip Applier Recalled for Clip Load Failure Risk

    Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load a clip after the trigger is actuated, potentially impacting surgical procedures.

    Product
    Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2024·2024-04-03

    Boston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak

    Boston Scientific is recalling specific batches of the iSLEEVE Expandable Introducer Set due to hemostatic valve leaks affecting 4,060 devices. The devices are distributed in the US, Canada, and worldwide.

    Product
    Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0394-2024·2024-04-03

    Diltiazem HCl Injection Lacks Sterility Assurance; SCA Pharmaceuticals Recalls

    SCA Pharmaceuticals is recalling Diltiazem HCl 125 mg Injectable (381 bags) due to lack of sterility assurance. Patients and healthcare providers should not use affected units from lot #1223049625.

    Product
    Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2024·2024-04-03

    Baxter Supple Peri-Guard Repair Patch Recall Due to Endotoxin Contraindication

    Baxter is recalling Supple Peri-Guard Repair Patch units due to elevated endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.

    Product
    Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1394-2024·2024-04-03

    IV Start Kit Recalled Due to Supplier Saline Syringe Issue

    Medical Action Industries is recalling 206,200 IV Start Kits due to saline syringes recalled by the supplier. The affected kits were distributed in Minnesota and North Dakota.

    Product
    IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2024·2024-04-03

    Thermalon Stye Compress recalled due to potential mold and mildew

    Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.

    Product
    Thermalon Stye Compress, Item Number 24352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0402-2024·2024-04-03

    fentaNYL 1,250 mcg Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling fentaNYL 1,250 mcg/25 mL injection syringes due to lack of sterility assurance. The nationwide recall affects 1,259 syringes; patients should contact their healthcare provider.

    Product
    fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1358-2024·2024-04-03

    Bio-Rad QXDx BCR-ABL diagnostic kit recalled for calibration errors

    Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.

    Product
    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0417-2024·2024-04-03

    Injectable Phenylephrine Recall Due to Sterility Assurance Failure

    SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 2024.

    Product
    PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2024·2024-04-03

    RELAY PRO Thoracic Stent-Graft System recalled for incorrect size

    Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.

    Product
    RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2024·2024-04-03

    Thermalon Back Wrap Recalled for Potential Mold and Mildew Growth

    Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.

    Product
    Thermalon Back Wrap, Item Number 24312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0408-2024·2024-04-03

    HYDROmorphone Injectable Recalled Due to Sterility Assurance Failure

    SCA Pharmaceuticals is recalling HYDROmorphone HCl injections due to lack of assurance of sterility. Patients who received the affected lot should contact their healthcare provider.

    Product
    HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0414-2024·2024-04-03

    Phenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues

    SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.

    Product
    PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2024·2024-04-03

    Epix Universal Clip Applier Recalled for Potential Clip Loading Failure

    Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.

    Product
    Epix Universal Clip Applier, REF: CA500, STERILEEO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0401-2024·2024-04-03

    FDA Recalls Fentanyl-Bupivacaine Injection Due to Sterility Assurance Concerns

    SCA Pharmaceuticals is recalling 130 cassettes of a fentanyl-bupivacaine epidural injection distributed nationwide due to lack of assurance of sterility.

    Product
    fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0418-2024·2024-04-03

    Phenylephrine HCl Injectable Recalled Nationwide for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling Phenylephrine HCl Injectable (400 mcg/10 mL) distributed nationwide due to lack of sterility assurance. Affected lot numbers have expiration dates through May 2024.

    Product
    PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2024·2024-04-03

    Laboratory performance verifier recalled for mismatched diluent assembly

    Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.

    Product
    VITROS Performance Verifier I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2024·2024-04-03

    Emergency traction splint adhesive failure may compromise device function

    Emergency Products & Research is recalling 190,000 O.T.D. traction splints because adhesive may fail to secure the pole insert, potentially compromising function in emergency medical situations.

    Product
    O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2024·2024-04-03

    Baxter Peri-Guard Repair Patch contraindicated for neurosurgical use

    Peri-Guard Repair Patch is now contraindicated for neurosurgery because its endotoxin level may exceed the limit allowable for cerebrospinal fluid-contacting devices. Product instructions have been updated.

    Product
    Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Drugs)·D-0423-2024·2024-04-03

    Succinylcholine chloride injection recalled for lack of sterility assurance

    SCA Pharmaceuticals recalls Succinylcholine Chloride 200 mg/10mL injectable due to lack of assured sterility. The recall affects 8,755 syringes distributed nationwide.

    Product
    SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V197000·2024-04-03

    2022 Hyundai Santa Fe and Santa Cruz Turbocharger Oil Pipe Fire Risk Recall

    Hyundai is recalling 2022 Santa Fe and Santa Cruz vehicles because the turbocharger oil supply pipe may crack, causing an oil leak that could increase fire risk in the engine compartment.

    Product
    HYUNDAI — 2022 HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide