
FDA•MODERATE
Duloxetine Delayed-Release Capsules
Direct Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.

Direct Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.

Acumed is recalling various hexalobe screws used in wrist fixation systems due to a risk of the screws breaking during use.
2 products
Amgen recalls Corlanor and Sensipar tablets over foreign substance contamination.
5 products
Zimmer recalls Off-Axis Reamer Guide (Model 110040240) due to breakage risk from catching during reaming.
5 products
PFM Medical is recalling Multi-Snare Set catheter devices due to a failure to meet biocompatibility requirements for in-vitro cytotoxicity.

Ventec is recalling the VOCSN+Pro respiratory system because a damaged battery may prevent the backup alarm from sounding during power loss.

Major Pharmaceuticals is recalling 0.2 mg Methylergonovine Maleate Tablets due to subpotency.

Ajanta Pharma is recalling Fenofibrate Capsules, USP 200 mg, due to manufacturing process deviations.

Philips recalls Avalon Fetal Monitor FM20 over speaker connector issue that may cause loss of speaker output.
2 products
Intuitive Surgical is recalling the Da Vinci surgical system E-brake retainer pin due to a risk of uncontrolled motion and patient injury.

TMJ Solutions is recalling custom temporomandibular joint implants due to incorrect components causing a poor fit and potential open bite.

MorningStar Farms recalls Buffalo Chik'n Nuggets and Hot & Spicy Sausage Patties over possible plastic contamination.
2 products
Arizer is recalling Solo III portable vaporizers due to fire and burn hazards affecting specific serial prefixes and UPC 628078802274.

BABESIDE doll and stroller sets are recalled due to a choking hazard from small parts that violate federal safety standards.

GOPO Toys is recalling pull string teething toys due to a serious choking hazard caused by strings that violate federal safety standards.

Joolz is recalling Aer2 car seat adapters because they can fail to attach to the stroller, posing a fall hazard to children.

CooCooBaby is recalling Classic and Deluxe baby loungers due to suffocation and fall hazards that violate federal infant sleep safety standards.

Michley children's pajamas are recalled for failing to meet federal flammability standards, posing a serious burn injury or death risk.

Veseacky children's pajama sets are recalled for violating federal safety standards, posing a serious burn injury or death risk to children.

Keystone recalls 20% benzocaine gels (Pearson, Quala, DHP, etc.) over defective seals.
7 productsThoratec recalls HeartMate 3 LVAS kits (model 106524US) due to 11V backup battery failures.
6 products
Inspire is recalling its Respiratory Sensing Lead (Model 4340) due to incorrect Use By Dates that may lead to premature revision surgery.
3 products
BD is recalling Connecta Luer-Lok stopcocks due to a potential connection failure at Port C when using plastic luer-lok syringes.

Merit Medical is recalling various Splashwire Hydrophilic Guide Wire models due to unsealed pouches that may compromise device sterility.
2 products
Par Health is recalling Buprenorphine HCl Injection due to crystallization identified as Buprenorphine free base.

Stryker recalls Triathlon Universal Baseplates due to size mislabeling in packaging.
2 products
Medline recalls Red Rubber Latex Urethral Catheters (REF DYND13508–DYND13522, DYND13614/16) over surface, connector, and diameter defects.
34 products
GE HealthCare recalls Giraffe OmniBed incubator/warmer over canopy soffit fastener risk that could injure patients.
3 products
ConMed recalls AirSeal 5 mm Access Port (iASB5-150) over overpressure alert risk.
11 productsStaar Surgical is recalling Version 8.00 of its ICL Calculation Software due to a coding error affecting toric lens orientation diagrams.
2 products
Arrogantf spa drain covers are recalled due to entrapment and drowning hazards, as they violate federal safety standards.

Nutrisystem is recalling Chocolate Cheesecake 2 oz packages due to an undeclared soy allergen.

Great Value Hawaiian Roll 4pk recalled over oily substance on food-contact packaging; product never reached store shelves.

Accriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control, level 2, due to incorrect performance range labeling.

Ajanta Pharma is recalling Aripiprazole 30 mg tablets due to a mix-up with Voriconazole 50 mg tablets.

Medtronic is recalling the O-arm O2 Imaging System due to a firmware anomaly that may cause image artifacts during clinical use.

HarmonyAIR A-Series surgical lights recalled: intensity buttons may detach.
2 products
Steris is recalling HarmonyAIR A-Series Surgical Lighting Systems due to a risk of paint delamination on the light heads.

Nara Organics is recalling Whole Milk Organic Infant Formula over potential Clostridium botulinum contamination.

Dabur India recalls 14 OTC topical products over CGMP deviations.
14 products
Chlorthalidone 25 mg tablets are being recalled due to failed dissolution specifications.

Sandoz is recalling Focalin XR 5 mg capsules due to missing or incorrect lot numbers and expiration dates on the product labels.

Glenmark is recalling Alyacen 7/7/7 tablets due to out-of-specification results for total impurities.

IntegraDose is recalling Vasopressin 2 Units/2 mL syringes due to subpotency, which may cause the drug to be ineffective.

VistaPharm recalls Kerr Insta-Char activated charcoal (25g/50g) for failing OTC monograph requirements.
4 products
Medline recalls EBSI Kit (EBSI1534) due to cracked butyrate tubing and recalled MASTISOL adhesive.
42 products
Abbott's Impella heart pumps may fail to restart after certain operational faults, posing a serious health risk to patients.
2 products
Arrow International recalls paracentesis kits due to supplier quality issues with included injectables, risking serious injury.
51 products
Hasuit 7-Drawer Dressers are recalled due to tip-over and entrapment hazards that violate federal safety standards.

Arctic Zone Titan Pro coolers are recalled due to a choking hazard from a detachable latch magnet.
