The Recall Desk

Archive

April 2024 recalls

478 recalls were announced in April 2024.

What the numbers show

Critical
6
Severe
89
High
326
Moderate
55
Low
2

Of the 478 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

Which agencies issued them

401–478 of 478

  • 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 (Drugs)·D-0399-2024·2024-04-03

    FDA Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 324 syringes of fentanyl/bupivacaine epidural injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if affected.

    Product
    fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1098-2024·2024-04-03

    Barsotti Organic Carrot Juice recalled due to under-processing

    Barsotti Organic Carrot Juice in 16 oz and 64 oz bottles (also sold under Trader Joe's label) is recalled because it was determined to be under-processed. This may allow harmful bacteria to survive.

    Product
    Barsotti Organic Carrot Juice 16 oz. and 64 oz. plastic bottles Perishable, Keep Refrigerated Ingredient: Fresh Pressed Organic Carrot Juice. Flash Pasteurized. Barsotti Juice Co., Camino, CA 95709 (530_ 622-4629 www.barsottijuice.com Trader Joe's 100% Juice Organic Carrot Ju
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1366-2024·2024-04-03

    MediBeads Neck Wrap recalled for potential mold and mildew growth

    Bruder Healthcare Company is recalling 430 units of MediBeads Neck Wrap (Item 34320) because the product may have been exposed to excessive moisture, creating potential for mold and mildew growth. Lot Number M053300, distributed in the US and Canada.

    Product
    MediBeads Neck Wrap, Item Number 34320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1094-2024·2024-04-03

    Himalayan Pain Relief Tea Contains Undeclared Pharmaceutical Drugs

    WS Global Inc is recalling Himalayan Pain Relief Tea nationwide due to undeclared pharmaceutical drugs—Diclofenac and Dexamethasone Acetate—that were not listed on the product label.

    Product
    Himalayan Pain Relief Tea for Gout and Hangover
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0413-2024·2024-04-03

    Neostigmine methylsulfate injection recalled nationwide due to sterility concerns

    SCA Pharmaceuticals is recalling 1,122 syringes of neostigmine methylsulfate injection nationwide due to inability to assure product sterility. The affected lot is 1223048138 (expiration 1/31/24).

    Product
    neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24E031000·2024-04-03

    Watson & Chalin Recalls SL2065 Steerable Lift Axle Suspension Systems

    Watson & Chalin is recalling SL2065 steerable lift axle suspension systems because bearing journals may not be fully seated, creating a risk of spindle fracture and crash.

    Product
    STEERING:LINKAGES:KNUCKLE:SPINDLE:ARM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V247000·2024-04-03

    Winnebago Recalls 2024 Access Trailers Due to GFCI Wiring Defect

    Winnebago is recalling 2024 Access travel trailers because incorrectly wired GFCI outlets may lack protection, increasing the risk of electrical shock.

    Product
    WINNEBAGO — WINNEBAGO ACCESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V251000·2024-04-03

    Audi vehicles may have deactivated front passenger airbags

    Volkswagen is recalling certain 2023-2024 Audi models because an electrical connection in the front passenger occupant detection system may loosen, disabling the front passenger airbag and preventing deployment during a crash.

    Product
    AUDI — AUDI Q8, RS Q8, Q5, S5 CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V249000·2024-04-03

    2023-2024 Aston Martin DBX Oil Cooler Hoses May Burst

    Aston Martin is recalling certain 2023-2024 DBX707 vehicles because oil cooler hoses may burst, causing sudden oil loss that could lead to engine failure and fire.

    Product
    ASTON MARTIN — ASTON MARTIN DBX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1109-2024·2024-04-03

    Nordic Naturals Baby Vitamin D3 Liquid Recalled for Elevated Levels

    Nordic Naturals has recalled its Baby's Vitamin D3 dietary supplement liquid due to elevated vitamin D3 levels. The recall affects approximately 5,564 bottles with lot number 234909.

    Product
    Nordic Naturals Baby s Vitamin D3 liquid, 400 IU (10 mcg) D3, 0.76 fl oz (22.5 mL) DIETARY SUPPLEMENT, dark glass bottle
    Category
    Drug
    Distribution
    28 states
  • HighFDA (Devices)·Z-1359-2024·2024-04-03

    Thermalon Eye Compress Recalled Due to Potential Mold and Mildew Growth

    Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed in the US and Canada.

    Product
    Thermalon Eye Compress, Item Number 2434
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0407-2024·2024-04-03

    Hydromorphone Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.

    Product
    HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
    Category
    Drug
    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-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 (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 (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 (Drugs)·D-0412-2024·2024-04-03

    Injectable midazolam HCl recalled due to sterility assurance failure

    SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL injectable nationwide because the manufacturer cannot assure sterility of the product. Users should consult their healthcare provider regarding affected lot numbers.

    Product
    Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
    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-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-1361-2024·2024-04-03

    Thermalon Sinus Compress Recalled for Potential Mold and Mildew

    Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.

    Product
    Thermalon Sinus Compress, Item Number 24332
    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 (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 (Devices)·Z-1360-2024·2024-04-03

    Thermalon Sinus Compress Recalled for Potential Mold and Mildew Growth

    Bruder Healthcare Company is recalling certain lots of Thermalon Sinus Compress due to potential mold and mildew growth from moisture exposure. The product was distributed in the US and Canada.

    Product
    Thermalon Sinus Compress (French), Item Number 24332F
    Category
    Medical Device
    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 (Food)·F-1103-2024·2024-04-03

    German Home Bakery Apple Coffee Cake Recalled for Undeclared Wheat and Yellow #5

    German Home Bakery Apple Coffee Cake is being recalled due to undeclared wheat and Yellow #5 food coloring. Consumers with wheat allergies or Yellow #5 sensitivity should not consume this product.

    Product
    German Home Bakery Apple Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0424-2024·2024-04-03

    Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure

    SCA Pharmaceuticals is recalling 5,079 syringes of Succinylcholine Chloride Injection nationwide due to lack of sterility assurance. Affected lots are #1223049085 and #1223049364.

    Product
    SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
    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-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 (Devices)·Z-1384-2024·2024-04-03

    SOLTIVE Pro SuperPulsed Laser recalled for non-compliant power cord

    Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.

    Product
    SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
    Category
    Medical Device
    Distribution
    0 states
  • 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-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
  • 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-0397-2024·2024-04-03

    Fentanyl-Bupivacaine Epidural Injection Recalled for Sterility Assurance Failure

    SCA Pharmaceuticals is recalling 242 bags of fentanyl-bupivacaine epidural injection due to lack of assurance of sterility. The affected lot may not meet required sterility standards.

    Product
    fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0409-2024·2024-04-03

    FDA recalls HYDROmorphone injection for lack of sterility assurance

    SCA Pharmaceuticals is recalling HYDROmorphone HCl injectable syringes nationwide due to lack of sterility assurance. The FDA issued this Class II recall affecting multiple lot numbers.

    Product
    HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0415-2024·2024-04-03

    Phenylephrine Injectable Drug Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling phenylephrine HCl injection syringes nationwide due to inability to assure sterility. Patients using recalled lots should contact their healthcare provider.

    Product
    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0416-2024·2024-04-03

    PHENYLephrine Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals recalls PHENYLephrine HCl injectable syringes nationwide due to lack of sterility assurance. The recall affects 1,118 syringes across two lot numbers distributed throughout the USA.

    Product
    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID fo
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0426-2024·2024-04-03

    Divalproex Sodium 250 mg tablets recalled for failed dissolution specifications

    Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets 250 mg nationwide due to failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2024·2024-04-03

    Medivance Neonatal ArcticGel Pads Recalled for Reduced Water Flow

    Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.

    Product
    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
    Category
    Medical Device
    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 (Devices)·Z-1370-2024·2024-04-03

    Alcon bulb irrigation syringes recalled due to sterile barrier compromise

    Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.

    Product
    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2024·2024-04-03

    Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect

    Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.

    Product
    OptiCross Coronary Imaging Catheter, REF H749518080120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1375-2024·2024-04-03

    Olympus Insufflation Unit UHI-4 Recalled for Air Supply Failure

    Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.

    Product
    Insufflation unit, UHI-4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2024·2024-04-03

    Endoscopic Lens Cleaner Recalled for Instruction Discrepancy Risk

    Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.

    Product
    InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1385-2024·2024-04-03

    SOLTIVE Premium SuperPulsed Laser Recalled for Incompatible Power Cord

    Olympus recalls the SOLTIVE Premium SuperPulsed Laser due to non-compliant power cords incompatible with regional electrical outlets. Approximately 203 units were distributed to Australia, Chile, Germany, Hong Kong, Japan, New Zealand, and Singapore.

    Product
    SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1369-2024·2024-04-03

    Cystatin C Calibrator Series CVS 2699 Recalled for Calibration Bias

    Randox Laboratories is recalling Cystatin C Calibrator Series CVS 2699 because it runs with negative bias compared to other methods, which could affect test accuracy on automated analyzers.

    Product
    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
    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-1373-2024·2024-04-03

    Clinical Laboratory Quality Control Device Recalled for Diluent Assembly Error

    Ortho-Clinical Diagnostics is recalling 11,224 units of VITROS Performance Verifier II due to incorrect diluent assembly, which may produce inaccurate quality control results and potentially erroneous patient test results.

    Product
    VITROS Performance Verifier II
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1367-2024·2024-04-03

    MediBeads King Pad Moist Heat Compresses Recalled for Potential Mold Growth

    Bruder Healthcare is recalling MediBeads King Pad moist heat compresses (item numbers 34120, 34120PM, 34125R) from certain lots due to potential mold and mildew growth from excessive moisture exposure.

    Product
    MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1108-2024·2024-04-03

    Emerald River Premium Thai Jasmine Rice Recalled for Glass Contamination

    Otis McAllister recalls Emerald River Premium Thai Jasmine Rice due to glass contamination. The product was distributed in Utah, Oregon, Texas, and Washington.

    Product
    Product LAbeled in part: "Emerald River Premium Thai Jasmine Rice ... Net Wt 50 lb (22.7 kg) ... UPC 0 28571 00474 6"
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0411-2024·2024-04-03

    Labetalol HCl Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.

    Product
    labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0410-2024·2024-04-03

    Hydromorphone Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling 909 syringes of HYDROmorphone HCl 30 mg/30 mL injection nationwide due to lack of assurance of sterility. Patients should not use affected lots and consult their healthcare provider.

    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0419-2024·2024-04-03

    Pharmaceutical Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling PHENYLephrine HCl 40 mg injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider and not use this product.

    Product
    PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
    Category
    Drug
    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 (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 (Drugs)·D-0395-2024·2024-04-03

    Fentanyl Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals recalls fentanyl 2,500 mcg/250 mL injection (548 bags) nationwide due to lack of assurance of sterility. The affected product may not meet pharmaceutical sterility standards required for injectable drugs.

    Product
    fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
    Category
    Drug
    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-0420-2024·2024-04-03

    PHENYLephrine HCl Injectable Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling PHENYLephrine HCl 800 mcg/10 mL injections due to lack of assurance of sterility. The recall affects 3,671 syringes distributed nationwide.

    Product
    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0398-2024·2024-04-03

    FDA Recalls SCA Fentanyl-Bupivacaine Epidural Injection Cassettes Lacking Sterility Assurance

    SCA Pharmaceuticals is recalling 613 cassettes of fentanyl-bupivacaine epidural injection nationwide due to lack of assurance of sterility.

    Product
    fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0425-2024·2024-04-03

    Vancomycin Injectable Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling 368 bags of vancomycin 1.25 g injectable nationwide because the company cannot assure sterility was maintained. The affected lot was distributed across the USA.

    Product
    VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
    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
  • ModerateFDA (Devices)·Z-1386-2024·2024-04-03

    Philips Patient Information Center Custom Ringtones Fail When Screen Locked

    Philips Patient Information Center iX running software version 4.X may not play custom ringtones when iOS screens are locked with a passcode. Approximately 257,183 units have been distributed worldwide. No injuries have been reported.

    Product
    Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1105-2024·2024-04-03

    Coffee cake recalled for undeclared Yellow #5 food dye

    Sunflour Bakery is recalling German Home Bakery Raspberry Coffee Cake due to undeclared Yellow #5 dye. The voluntary Class II recall affects 70 loaves distributed in California.

    Product
    German Home Bakery Raspberry Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1376-2024·2024-04-03

    Access Substrate Reagent Bottles Recalled for Missing Product Labels

    Beckman Coulter is recalling Access Substrate reagent bottles (REF 81906) due to missing product labels on certain manufacturing lots. While the missing labels may delay patient test result reporting, no incorrect results have been reported.

    Product
    Access Substrate, REF 81906, For use with the Access Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2024·2024-04-03

    Thermalon Heating Pads Recalled for Potential Mold and Mildew Growth

    Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.

    Product
    Thermalon Heating Pad, Item Number 24002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1106-2024·2024-04-03

    Food Recall: German Home Bakery Poppy Coffee Cake for Undeclared Yellow #5

    NRS Enterprises, Inc. (Sunflour Bakery) recalled 197 loaves of German Home Bakery Poppy Coffee Cake due to undeclared Yellow #5 dye. The product was distributed in California.

    Product
    German Home Bakery Poppy Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1102-2024·2024-04-03

    Sunflour Bakery Marzipan Coffee Cake Recalled for Undeclared Yellow #5

    NRS Enterprises, Inc. dba Sunflour Bakery is recalling Marzipan/Almond Coffee Cake because Yellow #5 was not declared on the label. The product was distributed in California.

    Product
    Marzipan/Almond Coffee Cake, 16 oz, in clear poly bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1097-2024·2024-04-03

    Bluebonnet Methylfolate Chewables Recalled for Label Unit Error

    Bluebonnet Nutrition is recalling EarthSweet Chewables CellularActive Methylfolate 1000 mcg due to a labeling error stating '1000 mg' instead of '1000 mcg' on the front label.

    Product
    EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with purple lid
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0427-2024·2024-04-03

    FDA Recalls VCF Contraceptive Film Due to Manufacturing Process Violations

    The FDA is recalling VCF Contraceptive Film due to manufacturing process deviations. Apothecus Pharmaceutical Corp. initiated the voluntary recall on March 21, 2024, affecting 17,280 cartons distributed nationwide.

    Product
    VCF CONTRACEPTIVE — VCF CONTRACEPTIVE (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1104-2024·2024-04-03

    FDA Recalls German Home Bakery Cherry Coffee Cake for Undeclared Yellow #5

    NRS Enterprises, Inc. is recalling German Home Bakery Cherry Coffee Cake due to undeclared Yellow #5. The product was distributed in California and may affect consumers with tartrazine sensitivity.

    Product
    German Home Bakery Cherry Coffee Cake, 16 oz, clear poly bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1125-2024·2024-04-03

    Dietary Supplement Recall: TestoFREAK Contains Sub-Potent Zinc Levels

    VRA Formulations is recalling TestoFREAK Maximize Testosterone Dietary Supplement due to sub-potent zinc content. Affected bottles were distributed domestically through internet sales.

    Product
    TestoFREAK Maximize Testosterone Dietary Supplement 60 capsules per dark amber bottle, 100 bottles per case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1387-2024·2024-04-03

    CareEvent Event Management System notification failure on locked iOS devices

    The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.

    Product
    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1363-2024·2024-04-03

    Thermalon Neck Wrap recalled due to potential mold and mildew growth

    Bruder Healthcare Company is recalling Thermalon Neck Wrap (Item Number 24322) from certain lots due to potential mold and mildew growth from excessive moisture exposure. Consumers should discontinue use and contact the manufacturer.

    Product
    Thermalon Neck Wrap, Item Number 24322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1095-2024·2024-04-03

    Juice Recall: Incorrect SKU Label on Golden Sunrise Cold Pressed Juice

    Pressery, LLC is recalling Golden Sunrise Cold Pressured Juice due to an incorrect SKU label. No illnesses or injuries have been reported.

    Product
    The label reads, "Golden Sunrise Cold Pressured Juice Carrot, Orange, Pineapple, Lemon, Ginger & Turmeric 11 fl. oz."
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·24V245000·2024-04-02

    2021 Jayco Redhawk motorhomes recalled for power steering connection defect

    Certain 2021 Jayco Redhawk motorhomes have a defective power steering connection that can cause sudden loss of power steering and brake assist, increasing crash risk. Dealers will replace the defective parts free of charge.

    Product
    JAYCO — JAYCO, ENTEGRA GREYHAWK PRESTIGE, GREYHAWK, ESTEEM, ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V246000·2024-04-02

    2024 Hyundai Santa Fe rearview camera obstruction recall

    The rearview camera image may be obstructed by a trailer parking assist message, reducing rearward visibility and increasing crash risk. An over-the-air software update will fix the issue.

    Product
    HYUNDAI — HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V244000·2024-04-01

    2023 Kia Forte: Front Suspension Control Arm Failure Risk

    Kia recalls certain 2023 Forte vehicles because the right front lower control arm may be improperly welded and fail, risking sudden loss of steering control and crashes.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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