
FDA•MODERATE
Cetrorelix Acetate for Injection Kit 0.25 mg
Meitheal Pharmaceuticals recalls Cetrorelix Acetate injection kits (NDC 71288-558-90) due to missing or duplicated needles.

Meitheal Pharmaceuticals recalls Cetrorelix Acetate injection kits (NDC 71288-558-90) due to missing or duplicated needles.

RefleXion X1 Radiotherapy System Model RXM1000 recalled for software defect causing incorrect radiation dose delivery.

Abbott is recalling ID NOW Influenza A & B 2 test kits due to a higher-than-expected rate of invalid test results.

SmartPak Equine is recalling smart & simple Turmeric Pellets due to elevated aflatoxin levels.

Valley Springs is recalling 100% Natural Bottled Water in 1 Gal jugs due to insanitary bottling conditions.
4 products
International Life Sciences is recalling the Artelon FlexBand Dynamic Matrix due to failure to meet bacterial endotoxin testing requirements.
3 products
BD Kiestra ReadA modules may experience connectivity issues after a reboot, potentially delaying plate retrieval.

Hitachi is recalling the Proton Beam Therapy System (PROBEAT-FR) due to a software anomaly that may cause patient positioning discrepancies.
2 products
Tippy Toes Apple Pear Banana baby food is being recalled due to potential patulin contamination.

Fagron Sterile Services is recalling Thiamine HCl 500 mg injection due to a lack of assurance of sterility.
5 products
Remel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.

Diagnostica Stago is recalling the STA Liatest D-Di kit due to a positive bias in D-Dimer measurements that may cause inaccurate results.
2 products
Somerset Therapeutics is recalling Dexamethasone Sodium Phosphate Injection (NDC 70069-025-10/01) due to out-of-specification impurities at expiry.

Diagnostica Stago is recalling STA Liatest Free Protein S kits due to the risk of inaccurate test results for normal patient plasma levels.

React Health PHOENIX 5L Oxygen Concentrator recalled due to devices not meeting quality specifications.

Fresenius Kabi is recalling the Ivenix Infusion System LVP due to a risk of the cassette loading lever breaking during use.

Pure Solutions recalling 1 fl oz sleep formula bottles due to undeclared milk allergen from bovine colostrum.

Coco's Italian Market is recalling its 8 oz. Cannoli Making Kit due to undeclared wheat and milk allergens.
2 products
Exactech is recalling the Equinoxe Ergo Modular Impactor Handle due to a missing cross-pin that may cause device failure.
2 products
GE Medical Systems is recalling Imactis CT-Navigation System (Models E85101LA, E85101LP) due to potential needle trajectory/tip position discordance.

IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.

Pro Numb is recalling 5% Lidocaine Tattoo Numbing Spray due to cGMP manufacturing deviations.
2 products
B. Braun is recalling 21GA Winged Infusion Sets (Model 7M2802) due to the risk of needle tips being dull, blunt, or breaking during use.
3 products
Howmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because external screws may loosen and detach during use.

On-X is recalling Model ONXMC-25/33 Mitral Heart Valve due to incomplete testing before distribution.

Tiki Bar Dark Chocolatey Peanut Butter & Pretzel is recalled due to an undeclared peanut allergen.

Beckman Coulter is recalling chemistry analyzers due to a software error that may cause system delays and impact patient diagnosis.
2 products
Medline is recalling cardiac procedure kits to clarify that the included chest drainage units are intended for adult patients only.

Medtronic is recalling MiniMed 780G insulin pumps (software 6.60-6.62) due to software defects that may cause inaccurate insulin delivery.
GE is recalling Centricity Universal Viewer software versions 5.0 and 7.0 due to a cybersecurity vulnerability that may expose user credentials.
4 productsCovidien is recalling Vital Sync software because bedside monitor alarms may fail to transmit to the remote monitoring system.
2 products
Tandem is recalling insulin infusion pumps in Czech Republic and Slovakia due to user guide translation errors that could cause unintended insulin delivery.

Preema Bright Red and Orange Food Colour Powder recalled for banned carmoisine and undeclared FD&C Yellow 5 and Red 40.
2 products
Teva is recalling Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications.
4 products
Olympus is recalling the MAJ-210 single use biopsy valve due to the risk of rubber fragments detaching during use.
2 products
ReCor Medical is recalling Paradise Ultrasound Renal Denervation System catheters that were intended to be scrapped and are not for use.
3 productsB. Braun is recalling the Cesk Northside Anesthesia Tray (Model 555076) due to potential cracking of the included adhesive tubing.
8 products
Ultradent is recalling Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011, due to crumbling and breakage risk.

Medline is recalling Medcrest surgical gowns due to fabric delamination risks that may lead to infection or delays in patient care.
3 products
Khee Trading is recalling frozen half shell oysters due to potential Norovirus contamination.

Taro Pharmaceuticals is recalling Diclofenac Sodium Topical Gel 3% (100 g) due to viscosity specification failure.

BD is recalling 10mL non-sterile Luer-Lok syringes (catalog 301029) due to incorrect Luer Slip syringes mixed into batches.

Lutronic is recalling CLARITY II Laser System (Model 1110200210) due to sparking and burn hazard.

Stratford Care USA is recalling Keto-C Antiseptic Wipes (50ct) due to misbranding; product contains non-medicated otic flush instead of labeled antiseptic.
36 products
Beacon Promotions is recalling 1.3 oz repackaged M&Ms Peanut candies due to undeclared milk, soy, and peanut allergens.
3 products
Gerber Arrowroot Biscuits (5.5 oz, UPC 015000005962) recalled for potential paper/plastic contamination in arrowroot flour.

Asteria Health is recalling 100 mg Testosterone sterile pellets due to the potential presence of metal particulate matter.
25 products
Granules Pharmaceuticals is recalling Trazodone Hydrochloride 50 mg tablets (NDC 70010-231-01) due to foreign tablets or capsules in bottles.

Radnostix is recalling Sodium Iodide (I-131) Therapeutic Oral Solution due to the presence of particulate matter.

Philips is recalling Azurion 3 and 7 M12 systems over a software defect that can cause unexpected patient table movement.
8 products