FDA Recalls in 2023
3,974 recalls found
December 2023
FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
The firm, inpeco, sent "Urgent: Medical Device Correction" letters dated 7/14/20 to its customers. The letter described the product, problem and actions to be taken. Action to be taken by the user: Be aware that the Secondary Sample Tube flagged with error 2132 or 1442 may be diluted: discard this Secondary Sample Tube or manage it according to your laboratory guidelines. Your service provider will contact you to schedule the upgrade of the software driver and language.ini with the new error message and error recovery displayed if error 2132 or 1442 occurs. Until the service visit please maintain awareness on this notice. Please transfer this notice to whom it might concern. Please complete and return the Field Safety Notice Receipt Confirmation form attached to this letter within 15 days directly to the email address specified in the email communication. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: Regulatory.Affairs@inpeco.com Phone: (+41) 919118 224
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
BBraun issued "URGENT MEDICAL DEVICE CORRECTION" letter on 2/7/21 to End-Users. Letter states reason for recall, health risk and action to take: 1. Review the Device Correction Notification in its entirety and ensure that all users in your organization of theabove-mentioned product, and other concerned persons are informed about this voluntary correction. 2. Identify your current inventory of the affected serial (s) within your facility, cease use and quarantine product subject to correction. Do not destroy any affected product. 3. Utilizing the attached Product Correction Acknowledgement form, record the total number of individual units. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Correction Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we have received your acknowledgement a BBMI representative will contact you to arrange for inspection and/or correction of the affected products. Should an issue occur, please report the event promptly to BBMI by contacting Medical Affairs Department at 1-800-854-6851.
Regard brand CABG Pack A and B - Spartanburg
Kits were packed into shipping boxes incorrectly.
An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to lacy.stewart@roiscs.com so a return can be arranged. 4) Notify: Notify immediately any customers to whom you have distributed or forwarded product affected by this recall. Include the recall letter to supplement your notification.
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)
SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result
Siemens Medical Solutions USA, Inc., provided Customer Information Letter on 3/3/21 to affected customers via CT063/20/S. Customers with valid email addresses emailed a copy of the CSAN via Adobe Mega Sign. The CSAN will be distributed to the remaining customers address via hand delivery by the Siemens Customer Service Engineer. The letter states reason for recall, health risk and action to take: Siemens Healthineers has developed software update syngo.CT VA30A_SP3 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide improvements related to the general system, examination and reconstruction processes, as well as improvements for dual energy post-processing. Following the corrective action, the cause has been eliminated and recurrence of the identified issues are prevented. This software update will be provided to you free of charge. How will the corrective action be implemented? Software update CT084/20/S will be performed onsite for SOMATOM X.cite (Model #11330001). For all other systems, the update CT064/20/S will be performed remotely. The remote software updates process will require approximately 180 minutes for completion. If you have any unresolved questions or you require technical support, please contact your local application specialists or your local service/sales organization at 1-800-888-7436.
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Failed Content Uniformity Specifications
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.
Chemical contamination: Presence of benzene
NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
CGMP Deviations: Stability data does not support expiry date.
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611.
Chemical Contamination; presence of benzene.
THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
MIX FRUIT ALOHA BOWL 3/48 OZ Packaged in clamshell container. UPC:840219170299
Potential Salmonella Contamination
Sprouts Tropical Fruit Blend NET WT 10 OZ (283g) UPC 8 26766 89490 1 Manutfactured Exclusively for Sprouts Farmers Market Phoenix, Arizona 90504
Salmonella
Aviator Dehydrated Tomato Halves, Net Wt. 4x2.27kg (5lbs)
Contains undeclared sulfites
Mixed Melon NET WT 9 OZ (255 g) UPC 8 26766 13926 2 & 18 OZ (1 LB 2 OZ) 510 g Dist. By: Renaissance Food Group LLC 4322 Moreland Ave Corley, GA 30288
Salmonella
Small Fruit Tray NET WT 1 LB 10 OZ (26 OZ) 737 g UPC 8 26766 19098 0
Salmonella
Shakespeare's Pizza, Four Cheese Pizza, 25 oz, Keep Frozen; UPC 686 148 000 050; pack size 20 per case.
Undeclared wheat
Manischewitz Magic Max's Dark Chocolate Coins, NET WT. 0.53 OZ (15g), UPC: 072700200387 Display Box UPC: 072700200356, 12 bags per case. Product packaged in gold foil in blue netting bags.
Undeclared milk due to mispackaging
Large Fruit Tray with Dip NET WT 73.5 OZ (4 LBS (.5 OZ) 2.08 kg UPC 8 26766 19101 7 Dist. By: Renaissance Food Group LLC Rancho Cordova, CA 95670
Salmonella
MELON LOUPE/DEW CHUNKS 50/2 OZ. Packaged in film. UPC: 840219178080
Potential Salmonella Contamination
MIXED FRUIT CUBE 1/2"-NO GRA 20 LBS. Packaged in buckets. UPC: 840219191096
Potential Salmonella Contamination
Kwik Trip Mixed Fruit, Item 930847. Net Wt 6 oz (170g). UPC 0 39779-00240 3. Produced & Distributed by Kwik Trip Inc., La Crosse WI
Potential Salmonella Contamination.
HMC Farms Nectarines 2lb Gusset Bag
Potential contamination with Listeria monocytogenes
MIXED FRUIT BURST 6/10 OZ Packaged in clamshell containers. UPC: 840219168357
Potential Salmonella Contamination
HMC Farms Peaches 2lb Gusset Bag
Potential contamination with Listeria monocytogenes
Bulk Frozen Cases: The 9" Vegan Pumpkin Pie bulk case has UPC 22518 84081 and the label is read in parts: 9" Vegan Pumpkin Pie WFM, BAKED BULK, 6 units/case. KEEP FROZEN - TRANSPORT AND STORE AT LESS THAN ZERO DEGREES F. Just Thaw and serve. Remove from freezer, removed plastic wrap, and let thaw in REFRIGERATOR overnight. Please keep refrigerated. NOT SHELF STABLE. Willamette Valley Pie Company 1651 Eska Way, Silverton, OR 97381. Individual Retail Packages: Whole Foods Market - Vegan Pumpki
Foreign object
Cantaloupe Chunks 9oz (255g) UPC 8 26766 13923 1 & 18 oz (1 LB 2 OZ) 5??g UPC 8 26766 13917 0 Dist By Renaissance Food Group, LLC 4322 Moreland Avenue, Conley, GA 30288
Salmonella
ICE CREAM BAR, MICHOACANA, es...natural, ROMPOPE, Net. Wt. 6 Fl. Oz., Packaged in a plastic bag. Frozen.
Undeclared Yellow #5, Yellow #6, and Red #40
Cantaloupe Chunks with Tajin 9 OZ (255 g) UPC 8 26766 13935 4 Dist By Reniassence Food Group LLC 4322 Moreland Avenue Conley GA 30288
Salmonella
TRADER JOE'S FRESH CUT FRUIT FRUITFUL MEDLEY NET WT 16 OZ (1 LB) 453g UPC 0054 9912 DIST & SOLD EXCLUSIVELY BY TRADER JOE'S MONROVIA, CA 95013
Salmonella
Kwik Trip Cantaloupe, Item 930541. Net Wt 6 oz (170g). UPC 0 39779-00213 7. Produced & Distributed by Kwik Trip Inc., La Crosse WI
Potential Salmonella Contamination.
Mixed Fruit: Mixed Fruit Burst 6/10 oz. UPC: 840219168357 Packaged in clamshell containers Mixed Fruit Chunk 4/32 oz. UPC: 840219109947 Packaged in clamshell containers Mixed Fruit Chunk 4/6 oz. UPC: 840219198606 Packaged in clamshell containers Mixed Fruit Chunks 1" 20 lb. UPC: 840219178912 Packaged in buckets Mixed Fruit Chunks 6/16 oz. UPC: 840219170480 Packaged in clamshell containers Mixed Fruit Chunks 3/30 oz. UPC: 840219165219 Packaged in clamshell containers Mixed Fruit Chunks 6/9 oz. U
Potential Salmonella Contamination
HMC Farms White Nectarines 2lb Gusset Bag
Potential contamination with Listeria monocytogenes
Sprouts Farmers Market Apple Fruit Medley 10 OZ (283g) UPC 8 26766 40543 5 & 20 OZ (1.25 LB) 566g UPC 8 26766 40544 2 Manufactured Exclusively for Sprouts Farmers Market, Phoenix, Arizona 85054
Salmonella
HMC Farms White Peaches 4lb box
Potential contamination with Listeria monocytogenes
Large Fruit Tray NET WT 73 OZ (4 LBS 9 OZ) 2.06 kg UPC 8 26766 19100 0 Dist. By: Renaissance Food Group, LLC Rancho Cordova, CA 95670
Salmonella
Sprouts Farmers Market Assorted Fruit Spears NET WT 20 OZ (1.25 LB) 566g UPC 8 26766 40542 8
Salmonella
The Candy Shop Rainbow Belts Net Wt. 10.5 oz. (298g) SKU Code: 400255786276
Product states gluten free, but ingredient statement declares modified wheat flour as an ingredient.
FRUIT TRAY W/DIP 3/5 LB, 3/36 OZ, 3/56 OZ, and 3/40OZ UPCs: 840219175454, 840219195926, and 840219171777. Packaged in trays.
Potential Salmonella Contamination
HMC Farms Nectarines 4lb bag
Potential contamination with Listeria monocytogenes
HMC Farms White Nectarines 4lb box
Potential contamination with Listeria monocytogenes
Shakespeare's Pizza, Extra Cheese Pizza, 25 oz, Keep Frozen; UPC 686 148 007 370; pack size 20 per case.
Undeclared wheat
Sprouts Farmers Fruit Tray NET WT 32 OZ (2 LB) 907g UPC 8 26766 89481 9
Salmonella
MIXED FRUIT MEDLEY 6/6 OZ, 4/16OZ. Packaged in clamshell containers. UPCs: 840219182445 and 840219124292
Potential Salmonella Contamination
HMC Farms Nectarines Signature Farms 2lb bag
Potential contamination with Listeria monocytogenes
Fruit Medley NET WT 9 OZ (255 g) UPC 8 26766 13927 9 & 18 OZ (1 LB 2 OZ) 510 g UPC 8 26766 13921 7 Dist. By: Renaissance Food Group LLC 4322 Moreland Ave Conley, GA 30288
Salmonella
Frozen, Lightly Seasoned Salmon Burgers, 28x6oz., 10.5 lbs cases
Contains undeclared sesame seeds and milk
Small Fruit Tray with Dip NET WT 26.75 OZ (1 LB 10.75 OZ) 758 g UPC 8 26766 19099 7 Dist By Renaissance Food Group, LLC 4322 Moreland Ave Conley, GA 30288
Salmonella