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Unapproved product recalls

Recalls tagged “Unapproved product”, newest first. 22 recalls
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1 recall

CooperVision Softmed Breathables Advanced Toric Contact Lenses

The contact lens is labeled for extended wear but is intended for daily wear only.

Moderate risk, FDA, Unapproved product

1 recall

Glypto Device, Glypto Cryo Machine

The Glypto Device and Glypto Cryo Machine lack 510(k) clearance.

Moderate risk, FDA, Unapproved product

1 recall

Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil

Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil contains garlic essential oil not approved for culinary use.

Moderate risk, FDA, Unapproved product

1 recall

Terex Utilities Power Over Fiber Base Module

The Power Over Fiber Base Module is not certified and is improperly labeled.

Moderate risk, FDA, Unapproved product

1 recall

Silent Nite Sleep Appliance

The Silent Nite Sleep Appliance lacks FDA clearance.

Moderate risk, FDA, Unapproved product

1 recall

BD Medline 111 Gravity Set

The gravity set was shipped as an engineering sample labeled not for human use.

Moderate risk, FDA, Unapproved product

1 recall

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Convenience kits with 10mL polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

1 recall

Covidien Mon-a-Therm Temperature Probes and Esophageal Stethoscope

Covidien Mon-a-Therm temperature probes lack FDA clearance.

Moderate risk, FDA, Unapproved product

1 recall

Erotic Enhancers WAP Sensual Enhancement Capsules

WAP Sensual Enhancement Capsules contain undeclared sildenafil, tadalafil, and flibanserin, which can lower blood pressure to dangerous levels.

High risk, FDA, Hidden drug ingredient

1 recall

DFI One Step and QUCARE In Vitro Diagnostic Tests

The One Step 10A in vitro diagnostic test was distributed without required FDA premarket clearance or approval.

Moderate risk, FDA, Unapproved product

1 recall

Healthmark Mesh Style Tip Protectors

Mesh Style Tip Protectors lack FDA clearance.

Moderate risk, FDA, Unapproved product

1 recall

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Medline Convenience Kits with 10mL polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

1 recall

Kian Pee Wan Capsules

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

High risk, FDA, Hidden drug ingredient

1 recall

ReCor Medical Paradise Ultrasound Renal Denervation Catheters

The Paradise catheter is nonconforming and not for human use.

Moderate risk, FDA, Unapproved product

1 recall

BiDop 3 Pocket Doppler Blood-Flow Detectors

The BiDop 3 Pocket Doppler has a fetal indication for use that is not cleared.

Moderate risk, FDA, Unapproved product

1 recall

Altruan Strep A At-Home Self-Tests

Altruan GmbH is recalling its Wondfo Streptococcal A At-Home Self-Test, Clearest Strep-A Cassette Test, and Bisaf Strep A Self-Test because of product not cleared by the FDA.

Moderate risk, FDA, Unapproved product

2 recalls

Mohamed Hagar Mojo Max Fusion XXX Capsules

Mojo Max Fusion XXX contains undeclared sildenafil and tadalafil.

High risk, FDA, Hidden drug ingredient

MR. 7 Super 700000 Capsules

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil.

High risk, FDA, Hidden drug ingredient

1 recall

Agebox iKids-Growth Day and Night Formula Capsules

Agebox iKids-Growth (Day Formula) capsules contain undeclared ibutamoren.

Moderate risk, FDA, Hidden drug ingredient

1 recall

PIE PAK and Trolley System

The PIE Trolley System lacks 510K clearance.

Moderate risk, FDA, Unapproved product

1 recall

Green Lumber Natural Fuel For Men Capsules

Green Lumber Natural Fuel For Men capsule contains tadalafil without approval.

High risk, FDA, Hidden drug ingredient

1 recall

123Herbals Silintan 25 Pills

Silintan capsules contain undeclared meloxicam, which can cause serious life-threatening events.

High risk, FDA, Hidden drug ingredient
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