Safety Recalls
RSS ↗15,186 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 3,151–3,200 of 15,186
- Class II
Medical Device Recall · November 24, 2025
Zimmer Air Dermatome, Model/Catalog Number: 00880100100The devices may have a misaligned thickness control bar.
- Class I
Medical Device Recall · November 24, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.A certain component of affected devices was not delivered within specification and contained impurities.
- Class II
Medical Device Recall · November 24, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
- Class II
Medical Device Recall · November 24, 2025
Zimmer Dermatome AN, Model/Catalog Number: 88710100The devices may have a misaligned thickness control bar.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Menopause Test Cassette (Urine)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo Vaginal pH TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Male Fertility Sperm Test for Home Use (Cassette)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Exploro Highly Sensitive Male Fertility / Sperm Concentration TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class I
Food Recall · November 22, 2025
Locatelli Pecorino Romano Cheese Grated (Wegmans #270010) Packaged and sold by the pound Packaged in cylindrical clear plastic tubs with lid UPC: 2-77580-XXXXX-7, where X is the unit price of the contProduct may be contaminated with Listeria monocytogenes.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
S. Typhi/Para Typhi A AntigenTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class I
Food Recall · November 22, 2025
EverRoast Chicken Caesar Salad 850042244142 Net Wt: 8.5 oz (255g)Potential presence of Listeria monocytogenes.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo Protein TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo pH TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone TTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
LH One Step Ovulation Test Device (Urine)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class I
Food Recall · November 22, 2025
EverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)Potential presence of Listeria monocytogenes.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; UriTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class I
Food Recall · November 21, 2025
Boar's Head Pecorino Romano Grated, 5-pound plastic bag (unit)Product tested positive for Listeria Monocytogenes.
- Class II
Medical Device Recall · November 21, 2025
Roche Diagnostics Operations, Inc.
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreIssues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
- Class II
Medical Device Recall · November 21, 2025
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.Emphasizing instructions for LVP duration programming located in the IFU.
- Class I
Food Recall · November 21, 2025
Silvestri Sweets Inc dba Carousel Candies
Choceur Pecan Cranberry & Cinnamon Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095829. Wholesale unit is split case, with 9 of each item per case.Undeclared wheat
- Class I
Food Recall · November 21, 2025
Pinna Grated Pecorino Romano 2/10, 10-pound plastic bags (units)Product tested positive for Listeria Monocytogenes.
- Class I
Food Recall · November 21, 2025
Silvestri Sweets Inc dba Carousel Candies
Choceur Cookie Butter Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095690. Wholesale unit is split case, with 9 of each item per case.Undeclared pecan
- Class I
Food Recall · November 21, 2025
Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per caseProduct tested positive for Listeria Monocytogenes.
- Class I
Food Recall · November 21, 2025
Ambriola Piccante grated Pecorino Romano, 5 and 10-pound plastic bags (units)Product tested positive for Listeria Monocytogenes.
- Class I
Food Recall · November 21, 2025
Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per caseProduct tested positive for Listeria Monocytogenes.
- Class I
Food Recall · November 21, 2025
Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per caseProduct tested positive for Listeria Monocytogenes.
- Class II
Food Recall · November 21, 2025
Lotus Mom Corporation dba Indian Kitchen Mart
Aluminum Kadai with Metal Handles Size 5. A-Cook MADE IN INDIA SIZE 5 Sticker label: $$24.99+TXPotential contamination with leachable lead.
- Class I
Food Recall · November 21, 2025
Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per caseProduct tested positive for Listeria Monocytogenes.
- Class II
Food Recall · November 21, 2025
Yoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per caseThe products contain an unallowed color Carmoisine (E122) - Acid Red 14.
- Class II
Food Recall · November 21, 2025
Lotus Mom Corporation dba Indian Kitchen Mart
Brass Tope. Sticker label: $29.99+TAXPotential contamination with leachable lead.
- Class I
Food Recall · November 21, 2025
SENNA LEAVES F/C OG Item No: SEN15001 Net Wt: 44.75 Lbs Distributed By Whole Herb Company 19800 8th Street East, Sonoma, CA 95476 UPC 10031 44312Potential contamination with Salmonella.
- Class II
Food Recall · November 21, 2025
Lotus Mom Corporation dba Indian Kitchen Mart
IKM Aluminum Saucepan 9" with Wooden Handle. Sticker label: ALUMINIUM PAN 2 SIDE POUTED WOODEN HANDLE 9" UPC 7 023672 411878 US $ 17.99 Sticker label: IKM INDIAN KITCHEN MARTPotential contamination with leachable lead.
- Class II
Food Recall · November 21, 2025
Yoyo Gummy Tropical Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per caseThe products contain an unallowed color Carmoisine (E122) - Acid Red 14.
- Class I
Food Recall · November 21, 2025
Lotus Mom Corporation dba Indian Kitchen Mart
Brass Pital Pot 4-quart. Sticker label: BRASS HAMMERED HANDI NO 3 UPC 7 023672 414398 US $ 74.99 Sticker label: IKM INDIAN KITCHEN MARTPotential contamination with leachable lead.
- Class III
Drug Recall · November 21, 2025
Glenmark Pharmaceuticals Inc., USA
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-8Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- Class II
Medical Device Recall · November 21, 2025
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
- Class II
Food Recall · November 21, 2025
Yoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per caseThe products contain an unallowed color Carmoisine (E122) - Acid Red 14.
- Class I
Food Recall · November 21, 2025
Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)Product tested positive for Listeria Monocytogenes.
- Class II
Medical Device Recall · November 20, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROGSoftware issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
- Class II
Food Recall · November 20, 2025
Sinus Cap Herbal Supplement, Herbs containing antibiotic, drying, expectorant, and emollient properties, Fenugreek, Thyme, Oregon Grape Root, & Bentonite Clay, 50 capsules/510 mg; packaged in a plastiUnapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- Class II
Medical Device Recall · November 20, 2025
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- DAutomated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
- Class II
Food Recall · November 20, 2025
Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic dropper bottleUnapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- Class II
Food Recall · November 20, 2025
Pain Away Herbal Supplement, Analgesic & anti-inflammatory properties, Wood Betony & White Willow in vegetable glycerin, packaged in a 4.5 oz. glass bottle or 9 oz. glass bottle, UPC 231946534537Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- Class II
Food Recall · November 20, 2025
Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, water; packaged in a 2 oz. glass dropper bottleUnapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- Class II
Food Recall · November 20, 2025
Baby Allergy Herbal Supplement, Contains: Echinacea Purpurea, Oregon Grape Root, Dandelion & Burdock Root, Fenugreek, Ginger Root in vegetable glycerin; packaged in a 2 oz. glass dropper bottle, UPC 2Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
- Class II
Drug Recall · November 20, 2025
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 871Incorrect Product Formulation
- Unclassified
Consumer Product Recall · November 20, 2025
Hangzhou Lingda Diannao Youxiangongsi, doing business as Mallimoda, of China
Mallimoda Children's Pajama SetsThe recalled pajama sets violate the mandatory standards for children's sleepwear, posing a risk of serious injuries or deadly burn hazard to children.
- Unclassified
Consumer Product Recall · November 20, 2025
Intimidator LLC d/b/a/Spartan Mowers and UTVs, Batesville, Arkansas
Model Year 2025 Spartan SRT-XD and KGZ-XD riding lawn mowersThe riding mower's steering arm dampers can be installed incorrectly, which can result in an unexpected bouncing motion and loss of operator control, posing a crash hazard.