Safety Recalls

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15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 9,401–9,450 of 15,364

Medical Device Recall · November 4, 2024
Straight Smile, LLC
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
Class II
Medical Device Recall · November 4, 2024
Philips North America Llc
dS Breast 7ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Food Recall · November 4, 2024
University Of Wisconsin Madison Babcock Hall Dairy Plant
Babcock Dairy Chocolate Peanut Butter Ice Cream, Half Gallon, University of Wisconsin-Madison. UPC 12316-01116.
Undeclared eggs and yellow #5.
Class II
Food Recall · November 4, 2024
Yoder's Cashew Crunch
Hard candy packed in clear plastic bag with gold/red label, Yoder's Cashew Crunch, Wt. 7oz, 2620 Hwy. 22, Riverside, IA 52327
Undeclared allergen labeling (milk)
Class II
Medical Device Recall · November 4, 2024
Philips North America Llc
SENSE Breast Coil 3.0T 7ch
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Food Recall · November 4, 2024
Tipp Distributors, Inc. dba Novamex
Jarritos Coconut Water 17.5 fl oz cans- 12 cans per carton
The hermetic seal on the lid of the cans may be compromised
Class II
Medical Device Recall · November 4, 2024
Philips North America Llc
ST SENSE Breast Coil
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Medical Device Recall · November 4, 2024
Philips North America Llc
dS Breast 16ch 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Medical Device Recall · November 4, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica CI Analyzer. Catalog Numbers: 10947347.
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
Class II
Drug Recall · November 4, 2024
Boulla LLC
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I
Drug Recall · November 4, 2024
Boulla LLC
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I
Drug Recall · November 4, 2024
Boulla LLC
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I
Drug Recall · November 4, 2024
Boulla LLC
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I
Medical Device Recall · November 4, 2024
Philips North America Llc
dS Breast 7ch 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Medical Device Recall · November 4, 2024
Philips North America Llc
Mammotrak Interventional Coil 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Vehicle Recall · November 4, 2024
Tiffin Motorhomes, Inc.
2023 TIFFIN ALLEGRO OPEN ROAD, 2024 TIFFIN ALLEGRO OPEN ROAD
A circuit board that overheats increases the risk of a fire.
Unclassified
Medical Device Recall · November 4, 2024
Philips North America Llc
dS Breast 16ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Food Recall · November 4, 2024
Sweet Sam's Baking Company, LLC
Sweet Sam's Individually Wrapped Chocolate Chunk Brownie 12- pack Individually Wrapped 3.2 oz Chocolate Chunk Brownies
Contains undeclared soy lecithin
Class II
Medical Device Recall · November 4, 2024
Philips North America Llc
Mammotrak Diagnostic Coil 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Food Recall · November 4, 2024
Yoder's Cashew Crunch
Hard candy packed in clear plastic bag with gold/red label, Yoder's Cashew Crunch, 14oz, 2620 Hwy. 22, Riverside, IA 52327
Undeclared allergen labeling (milk)
Class II
Food Recall · November 4, 2024
Yoder's Cashew Crunch
Yoder's Cashew Crunch Corn, bulk candy coated popcorn packaged in clear plastic without label.
Undeclared allergen labeling (milk)
Class II
Medical Device Recall · November 4, 2024
Philips North America Llc
ST SENSE Breast Dx Coil
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Medical Device Recall · November 4, 2024
Philips North America Llc
SENSE Breast Coil
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Class II
Medical Device Recall · November 1, 2024
Cardinal Health 200, LLC
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Class II
Medical Device Recall · November 1, 2024
Becton, Dickinson and Company, BD Bio Sciences
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
Class II
Medical Device Recall · November 1, 2024
Medtronic Neurosurgery
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Class I
Medical Device Recall · November 1, 2024
Becton, Dickinson and Company, BD Bio Sciences
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluo
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pit
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Food Recall · November 1, 2024
Levi A. Bontrager
L & L Homemade Corn Salsa in 16 oz Glass jar. W1520 Starr Road, Granton, WI 54436
Salsa had pH of 4.7.
Class II
Food Recall · November 1, 2024
Lithuanian Bakery, Inc.
Napoleonas Torte packaged under the following sizes: 1. Small, Net Wt 1.25 lbs. (sub ingredients contain wheat, yellow #5 and #6, and sulfites not declared on final product label) 2. Medium, Net W
Products contain undeclared allergens (milk, soy, and wheat) and undeclared sulfites, yellow 5, yellow 6.
Class I
Food Recall · November 1, 2024
GRIFFITH FOODS LTD
Item 16354301, MAXI - 44067705 - MAXI KR BA BA 3040 EX, 55.115 lb. bag
potential for pieces of metal in product
Class II
Food Recall · November 1, 2024
Ocean Group Inc.
SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB SALMON NORWAY 6/7KG FR NOR F LB SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB SALMON HIDDENFJORD FAROE ISLANDS 6/7KG FR F LB SALMON BAKKAFROST FAR
Potential for contamination of Listeria monocytogenes. Environmental sample collected by FDA yielded positive results for one Zone 1 (cutting board) and one Zone 3 (floor drain).
Class II
Medical Device Recall · November 1, 2024
Medtronic Neurosurgery
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACT
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Class I
Medical Device Recall · November 1, 2024
Securitas Healthcare LLC
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
Class II
Food Recall · November 1, 2024
The JM Smucker Company LLC
Great Value Cheese Danish 16.5 oz UPC 078742201177, 12 retail units per case
Pieces of plastic in product
Class II
Food Recall · November 1, 2024
Lithuanian Bakery, Inc.
Chocolate Raspberry: Three sizes, 1. Small, Net Wt 1.25 lbs. (sub ingredients contain, yellow #5 and #6, and red #40 not declared on final product label) 2. Medium, Net Wt 2.75 lbs. (sub ingredient
Products contain undeclared allergens (milk, soy, peanut, and wheat) and undeclared sulfites, yellow 5, yellow 6, and red 40)
Class II
Vehicle Recall · November 1, 2024
Altec Industries, Inc.
2023 ALTEC AERIAL DEVICE
A short circuit increases the risk of a fire.
Unclassified
Medical Device Recall · November 1, 2024
Becton, Dickinson and Company, BD Bio Sciences
FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, an
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
Class II
Medical Device Recall · November 1, 2024
Kreatech Biotechnology Bv
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.
Class II
Food Recall · November 1, 2024
Kim-Seng Company
"***SUPER***BRAND***DRIED CINNAMON POWDER***Net Wt: 4oz(113g)***PRODUCT OF CHINA***DISTRIBUTOR: IHA BEVERAGE COMMERCE, CA, 90040***"UPC#610232012476
Elevated lead > 2ppm
Class II
Medical Device Recall · November 1, 2024
Cardinal Health 200, LLC
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Class II
Food Recall · November 1, 2024
The JM Smucker Company LLC
Great Value Cinnamon Rolls 16.5oz UPC 078742201160, 12 retail units per case
Pieces of plastic in product
Class II
Medical Device Recall · November 1, 2024
Becton, Dickinson and Company, BD Bio Sciences
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Medical Device Recall · November 1, 2024
Becton, Dickinson and Company, BD Bio Sciences
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
Class II
Food Recall · November 1, 2024
GRIFFITH FOODS LTD
Item 42081001, 104023600 SPICY BREADING EXPORT, 50 lb. bag
potential for pieces of metal in product
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of In
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Food Recall · November 1, 2024
GRIFFITH FOODS LTD
Item 25293502, ADHESION BREADER EX, 50 lb. bag
potential for pieces of metal in product
Class II
Drug Recall · November 1, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pi
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II
Food Recall · November 1, 2024
GRIFFITH FOODS LTD
Item 79588401, ITAL STY PD HERB REDUCED EX, 55 lb. bag
potential for pieces of metal in product
Class II