Health recalls
3,673 recalls on record
The latest health recalls, updated daily from federal safety data.
Showing the 60 most recent of 3,673 health recalls.
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use…
Lack of Assurance of Sterility
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL)…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral…
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break.
Madewell Double V-Neck Pullover and V-Neck Cardigan Sweaters
The recalled sweaters violate the mandatory standard for clothing textiles, posing a risk of serious burn injuries or death.
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured…
Failed Impurities/Degradation Specifications
Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco…
Subpotent drug
Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo…
Subpotent drug
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by:…
Subpotent drug
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1…
cGMP deviations
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Surgical dressing manufactured out of specification (greater thickness).
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. …
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla…
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose…
Lack of Assurance of Sterility
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol)…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC…
Presence of Foreign Substance
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG …
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
RayCare 2024A SP1. Oncology Information Systems.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 …
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR …
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) …
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE…
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr…
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; …
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST…
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART …
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL)…
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle,…
Failed Impurities/Degradation Specifications
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle,…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial,…
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
CVS Health Medicated Hemorrhoidal Wipes
The recalled medicated wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging of the wipes is not child-resistant, posing a risk of serious injury or death from poisoning if the contents of the wipes are ingested by young children.
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt.,…
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand…
Presence of Foreign Substance.
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC…
Presence of Foreign Substance.
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma…
CGMP Deviations
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One…
CGMP Deviations
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346…
sub potency
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines &…
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US…
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs,…
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide …
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured…
Defective container:may contain bottles with incomplete seals
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield…
CGMP Deviations; deficiencies observed during FDA inspection
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor,…
Defective container:may contain bottles with incomplete seals
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin…
CGMP Deviations; deficiencies observed during FDA inspection
Latest across all categories
EEMB Lithium-ion Coin Battery Chargers with Rechargeable 2032 Batteries
The recalled battery chargers violate the mandatory standard for consumer products containing button cell or coin batteries, because the charger has lithium coin batteries that can be accessed easily by children. In addition, the coin batteries provided with the battery charger are not in child-resistant packaging, and the packaging does not have the warnings, as required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
DR Power PRO MAX30 30" Walk-Behind Power Lawn Mowers
The recalled mowers violate the mandatory safety standard for walk-behind power lawn mowers because the blades can operate without the blade control system engaged or continue to operate even after the release of the control, posing a serious laceration hazard.
Laziza Dressers
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.