Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 12,951–13,000 of 15,379
- Class II
Medical Device Recall · March 27, 2024
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- Class II
Medical Device Recall · March 27, 2024
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. However, the key of the subject laser products can be removed from key switch and the laser remains on. This is a safety concern.
- Class II
Medical Device Recall · March 27, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- Class III
Food Recall · March 26, 2024
PIES & SIDES HASHBROWN CASSEROLE, ALLERGENS: MILK, WHEAT, SOY, FISH, PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the label does not list the ingredients for their products.
- Class I
Food Recall · March 26, 2024
PIES & SIDES DEEP SOUTH TOMATO PIE, INGREDIENTS: SLICED TOMATOES, PIMENTO CHEESE, BLEACHED FOUR, MILK PRODUCTS, SPICES. CONTAINS: SOY, FISH, WHEAT, MILK PIES & SIDES MOUNT HOLLY, NCThe firm was notified that the label did not list any sub ingredients. The product contains pimento cheese which is made with mayonnaise which may include eggs. Undeclared eggs.
- Class I
Medical Device Recall · March 26, 2024
BiPAP V30 Auto Ventilator, Part Number 1111178Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
- Class I
Food Recall · March 26, 2024
PIES & SIDES PUMPKIN PIE 10.5 oz INGREDIENTS: PUMPKIN FILLING, SUGARS, VANILLA, BLEACHED FLOUR, SPICES, CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the product contains undeclared milk and eggs. The label fails to list any sub ingredients and the contain statement does not list milk or eggs.
- Class II
Drug Recall · March 26, 2024
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: CiShort fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
- Class III
Food Recall · March 26, 2024
PIES & SIDES SQUASH CASSEROLE CONTAINS: MILK, EGGS, SOY, FISH, WHEAT PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the product label fails to list any ingredients.
- Class III
Food Recall · March 26, 2024
PIES & SIDES SWEET POTATO CASSEROLE CONTAINS: EGG, MILK PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the product label fails to list any ingredients.
- Class I
Food Recall · March 26, 2024
PIES & SIDES BAKED MAC AND CHEESE, ALLERGENS: MILK, PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the label fails to declare the allergen egg as an ingredient or in the allergen statement. The firm was also notified that the label does not list any of the ingredients for their product.
- Class III
Food Recall · March 26, 2024
PIES & SIDES DOT'S POTATO BAKE 2lb INGREDIENTS: IDAHO POTATOES, MONT JACK, CHEDDAR, SHARP CHEEDAR, & CREAM CHEESES. SOUR CREAM, CHICKEN BROTH, BUTTER, CHIVES, SPICES. CONTAINS: MILK, SOY, FISH PIES &During an inspection by NCDA, the firm was notified that the label fails to list any sub ingredients.
- Class II
Medical Device Recall · March 26, 2024
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503NComplaints have been received with allegations of Incorrect Needle Curvature.
- Class III
Food Recall · March 26, 2024
PIES & SIDES Broccoli Casserole Contains: Wheat, Eggs, Milk, Soy, Fish PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the label does not list any ingredients in the product.
- Class II
Medical Device Recall · March 26, 2024
Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- Class II
Medical Device Recall · March 26, 2024
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBPBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- Class II
Medical Device Recall · March 26, 2024
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c)Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- Class II
Food Recall · March 26, 2024
5 lb.Food Club All Purpose Flour Best if Used by 03/08/2025undeclared milk, egg, and soy
- Class III
Food Recall · March 26, 2024
PIES & SIDES CONNIE'S CARAMEL APPLE PIE 11 oz INGREDIENTS: APPLE PIE FILLING, SUGARS, VANILLA, CARAMEL EXTRACT BLEACHED FLOUR, SPICES, CONTAINS: WHEAT, PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the label does not list the sub ingredients for their products.
- Class II
Drug Recall · March 26, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product ofFailed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
- Class I
Medical Device Recall · March 26, 2024
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical pDue to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
- Class III
Food Recall · March 26, 2024
PIES & SIDES CHERRY PIE INGREDIENTS: CHERRY PIE FILLING, SUGARS, VANILLA, BLEACHED FLOUR SPICES. CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the label does not list the sub ingredients for their products.
- Class I
Food Recall · March 26, 2024
PIES & SIDES MO' MONEY PIE INGREDIENTS: BLACK EYED PEAS, COLLARDS, ELBOW PASTA, CHEESES, CORNMEAL, BLEACHED FLOUR, MILK PRODUCTS, SPICES. CONTAINS: MILK, EGG, WHEAT PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the label fails to declare the allergen soy as an ingredient. The firm was also notified that the label does not list any sub ingredients or the allergen soy in the contains statement.
- Class III
Food Recall · March 26, 2024
PIES & SIDES GREEN BEAN CASSEROLE, CONTAINS: MILK, SOY, FISH, WHEAT, PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the label does not list the ingredients for their products.
- Class III
Food Recall · March 26, 2024
PIES & SIDES STRAWBERRY PIE INGREDIENTS: STRAWBERRY PIE FILLING, SUGARS, VANILLA, BLEACHED FLOUR, SPICES, CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the product label fails to list any sub ingredients.
- Class III
Food Recall · March 26, 2024
PIES & SIDES PEACH PIE INGREDIENTS: PEACH PIE FILLING, SUGARS, VANILLA, BLEACHED FLOUR, SPICES, CONTAINS: WHEAT PIES & SIDES MOUNT HOLLY, NCDuring an inspection by NCDA, the firm was notified that the label fails list any sub ingredients.
- Class I
Medical Device Recall · March 26, 2024
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R11111Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
- Class I
Medical Device Recall · March 26, 2024
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR11111Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
- Class III
Drug Recall · March 25, 2024
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10Failed Impurities/Degradation Specifications
- Class II
Medical Device Recall · March 25, 2024
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic componentDue to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Class I
Medical Device Recall · March 25, 2024
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
- Class II
Medical Device Recall · March 25, 2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic componentDue to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Class II
Drug Recall · March 25, 2024
Amneal Pharmaceuticals of New York, LLC
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.Failed Dissolution Specifications
- Class II
Medical Device Recall · March 25, 2024
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentDue to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Class II
Medical Device Recall · March 25, 2024
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentDue to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Class II
Medical Device Recall · March 23, 2024
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and PreUltrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
- Class I
Drug Recall · March 23, 2024
Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , ManChemical Contamination: Product manufactured with ethanol API that contains methanol
- Class I
Drug Recall · March 23, 2024
Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5Chemical Contamination: Product manufactured with ethanol API that contains methanol
- Class II
Food Recall · March 23, 2024
The Coastal Companies DBA Hearn Kirkwood
Egg salad sandwich packaged in clamshell for individual sale. 7.22oz (205g) UPC 766375938415Tuna salad sandwich was mislabeled as an egg salad sandwich. There is an undeclared allergen of fish (Tuna).
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998CA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D,A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
48" Lead Wires, Replacement Part Number: 1067724-4Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211AA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class III
Food Recall · March 22, 2024
12 oz Aluminum cans of root beer packaged 12 cans per carton. 2/12pks per caseProduct was mislabeled. Can labeled as regular Mug contains Mug Zero Sugar
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.Product demonstrates low viscosity.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503FA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929KA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.