Health recalls
3,707 recalls on record
The latest health recalls, updated daily from federal safety data.
Showing the 60 most recent of 3,707 health recalls.
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by:…
shortfill; reports of empty capsules.
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only,…
Presence of Particulate Matter; identified as stainless steel
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog…
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right …
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog…
Due to a defective circuit board that overheats
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. …
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following…
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by:…
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per…
Presence of precipitate
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray…
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder…
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:…
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90,…
Lack of Assurance of Sterility
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose…
Subpotent Drug
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80…
Lack of Assurance of Sterility
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose…
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose…
Subpotent Drug
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL),…
Presence of Particulate Matter: Hair was found in products
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose…
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose…
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose…
Subpotent Drug
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%),…
Lack of Assurance of Sterility
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25…
Presence of Particulate Matter: Hair was found in products
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL…
Lack of Assurance of Sterility
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into…
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401;…
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience…
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
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.
Latest across all categories
FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories
The recalled hockey visors and replacement visor accessories can crack upon impact, posing a risk of injury due to laceration or impact hazards.
Goal Zero YETI 3000X Portable Power Stations
The recalled power station's circuit board can overheat, posing a risk of serious injury from fire and burn hazards.
JINHEZO Mini Waterproof LED Tea Lights
The LED Tea Lights violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.