
FDA•MODERATE
APTUS 2.5 TriLock Screws
Medartis is recalling APTUS 2.5 TriLock Screws (model A-5750.16/1) due to a mix-up with 2.8mm screws.
2 products
Medartis is recalling APTUS 2.5 TriLock Screws (model A-5750.16/1) due to a mix-up with 2.8mm screws.
2 products
Exactech recalls Equinoxe Core Instrument Kit and Ergo Impactor Handle over missing cross-pin risk.
2 products
Raz Design is recalling various mobile shower commode chairs due to a seat bracket issue that may pose a fall risk to users.
2 products
BD is recalling 10mL non-sterile Luer-Lok syringes (catalog 301029) due to incorrect Luer Slip syringes mixed into batches.

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

Kirkman recalls Vasocaine Spray and Zone 1/2 Lidocaine Creams over unsupported expiry dates.
3 products
Medline is recalling the Nail Kit (model DYKM1528) because the included sterile saline wound wash may not meet sterility requirements.
5 products
Cipla recalls Nilotinib 150 mg and 200 mg capsules over failed specification tests.
2 products
Major Pharmaceuticals is recalling Midodrine Hydrochloride Tablets 5 mg (NDC 0904-6818-06) due to inadequately sealed blister packaging.

Olympus is recalling the MAJ-210 single use biopsy valve due to the potential for rubber fragments to detach during use.
2 productsDatascope is updating the Instructions for Use for the CS300 IABP (software version C.01) to correct battery runtime and cycle specifications.
2 products
Diagnostica Stago is recalling the STA Liatest Free Protein S kit due to potential underestimation of protein S levels in normal plasma.

Acme United is recalling 22 varieties of BZK Antiseptic Towelettes due to manufacturing process deviations.
22 products
Harbin Jixianglong recalls semaglutide bulk API over CGMP validation failures.
2 productsB. Braun recalls 21G winged infusion sets due to risk of dull or broken needle tip.
3 products
Aesculap is recalling the Minop Trocar 150mm because the shaft may be too long.

Siemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.

Teva recalls Metoprolol Succinate ER tablets (25-200 mg) over failed dissolution specs.
4 products
Abiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products
Roche is recalling Cobas Pro analytical units due to a software defect that can cause the system to report erroneous, repeated test results.
2 products
GE Healthcare is recalling Centricity Universal Viewer software due to a risk of patient information and image mismatch.

KOI fish balls are being recalled because they contain undeclared wheat and sesame, which are allergens and pose a risk to people with wheat or sesame allergies.
3 products
Medtronic is recalling Octopus Nuvo Tissue Stabilizer (TSMICS1) due to incorrect tubing assembly that may affect surgical tissue stabilization.

Remel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.

Agiliti is recalling the Adapt Pump (model 61600200) for a software failure that prevents the Microclimate Management function from restarting.

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

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

Medline is recalling kits containing Tego Connectors due to potential silicone seal defects that may cause fluid leakage or therapy delays.
6 products
Encore Medical is recalling EMPOWR 3D Knee and RSP Humeral Socket implants due to incorrect labeling.
3 products
Edermy is recalling PIE PAK trolley systems (models P2HC-A, P2HC-S, P2HC) due to a lack of required 510(k) clearance.
2 products
Slate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.

AvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.

LEO Pharma is recalling Adbry (tralokinumab-ldrm) injection due to a lack of sterility assurance following the discovery of wool fiber.

Gerber Arrowroot Biscuits (5.5 oz, UPC 015000005962) recalled for potential paper/plastic contamination in arrowroot flour.

McCain Foods recalls Ore-Ida Tater Tots and Sonic Tots over possible small hard plastic fragments.
2 products
Kirkland Signature Mini Beignets are recalled due to undeclared hazelnut, which poses a risk to consumers with allergies.

Accord BioPharma is recalling Udenyca injection due to improper storage temperature conditions.

American Health Packaging is recalling Oxycodone 5 mg tablets due to defective blister card seals that may cause tablets to fall out.

Meitheal Pharmaceuticals is recalling Cetrorelix Acetate injection kits due to missing or duplicated needles in the delivery system.

Olympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products
Laerdal is recalling LCSU 4 RTCA suction units due to potential electromagnetic noise levels exceeding regulatory limits.

Medline is recalling various surgical and biopsy convenience kits due to potential issues with the sterility assurance level.
62 products
Auris Health is recalling MONARCH Platform Bronchoscopy systems due to a software issue that may cause unexpected robotic arm repositioning and contact with the patient.

Stryker is updating the MOLLI 2 System labeling due to the risk of magnetized surgical tools dislodging markers during tissue removal.
2 products
Ambrosia Brands is recalling Rosabella Moringa dietary supplement capsules due to potential Salmonella contamination.

Fresenius Kabi recalls thiamine HCl 500 mg/100 mL IV bags over sterility concerns.
5 products
Integra LifeSciences is recalling MediHoney Gel dressing models 31805 and 31815 due to a potential breach in the sterile packaging barrier.
3 products
Asteria Health recalls Testosterone 100 mg Sterile Pellets over possible metal contamination.
25 products
Taro Pharmaceuticals is recalling Diclofenac Sodium Topical Gel 3% (100 g) due to viscosity specification failure.

Unichem is recalling Doxazosin Tablets 4 mg (NDC 29300-353-10) due to incorrect tablet imprinting that may cause medication errors.
