
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
Joy Gourmet recalls Joy brand lassi drinks over inadequate pasteurization.
14 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
Boichik Bagels recalls Whitefish Salad, Tuna Salad, and Pumpernickel Mix Bagels over undeclared eggs.
3 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
Power Plate Meals recalls 5,795 lbs of frozen meatloaf with garlic mashed potatoes due to undeclared soy allergen.

Keystone recalls 20% benzocaine gels (Pearson, Quala, DHP, etc.) over defective seals.
7 products
Fairhope Roasting recalls Cold Brew Concentrate; missing 'Keep Refrigerated' label on 1-gallon jugs.
Thoratec recalls HeartMate 3 LVAS kits (model 106524US) due to 11V backup battery failures.
6 products
International Food Products recalls dressing stabilizer and dairy powders over possible Salmonella.
3 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
Adndale Magnesium Glycinate Gummies are being recalled due to the presence of undeclared melatonin.

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
Philips recalls MultiDiagnost Eleva systems over hand switch that may not release, risking unintended radiation.
3 products
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.

AMD Medicom recalls Ritmed Neurological Sponges due to elevated endotoxin risk; full REF list on FDA page.
2 products
Accriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control, level 2, due to incorrect performance range labeling.

MID DOLCIARIA recalls Cannoli Siciliani and Crunchy Cannoli Gluten Free over unapproved colors E140/E141.
2 products
Smith & Nephew is recalling the Trigen Proximal Straight Humeral Nail due to a manufacturing error that may cause surgical delays or revision.

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.

Pepperoni Rolls recalled for undeclared milk allergen and improper refrigeration; 5 oz packages.

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

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
Golden State Medical Supply is recalling Niacin Extended-Release Tablets, 1,000 mg, due to failure to meet dissolution specifications.
2 products
Fresh Roast Systems is recalling the ColorTrack instrument (Model BENCH R-100) due to a potential laser safety hazard.

AVID Medical recalls Halyard Pain Pack kits (AMPK48-01) over possible lack of sterilization.
4 products