cpsc regulated Recalls

Straumann USA Recalls Impression Caps Over Mix-Up Hazard

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.

VANTIVE US Healthcare Recalls Dialyzer Over Dislodgement Risk

VANTIVE US Healthcare recalled 230,596 units of the PRIMSAFLEX M100 Set on January 6, 2026. The recall follows a risk of dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

VANTIVE US Healthcare Recalls Dialyzer Over Dislodgement Risk

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Medline Recalls Sterile Saline Wound Wash Over Sterility Concerns

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Medline Recalls Saline Wound Wash Over Sterility Concerns

Medline Industries recalled 104,608 units of sterile saline wound wash on January 5, 2026. The product may not have met the required sterility assurance level. Consumers should stop using this product immediately and follow recall instructions.

Encore Medical Recalls EMPOWR Acetabular System Over Packaging Errors

Encore Medical, LP recalled 49 units of the EMPOWR Acetabular System on January 5, 2026. Packaging errors may cause surgical delays, potentially affecting patient safety. Healthcare providers should stop using these devices immediately.

Biomerieux Recalls VITEK 2 Antibiotic Susceptibility Cards Due to False Results

Biomerieux recalled 2,668,954 VITEK 2 Gram-negative susceptibility cards on January 5, 2026. The recall addresses potential false resistant results for certain antibiotic tests. Healthcare providers and patients must stop using the product immediately.

Medline Nail Kit Recalled Over Sterility Concerns

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Medline Recalls Convenience Kits Over Sterility Concerns

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

AVID Medical Recalls Transport Bag Kit Over Sterility Risk

AVID Medical recalled 1,500 units of the TRANSPORT BAG KIT on January 2, 2026. A seal issue with the Tyvek bag may compromise the sterility of the kit. The recall affects healthcare providers and patients in New Jersey.

Alphatec Spine Recalls Surgical Instruments Over Connection Issue

Due a design issue where the navigated array connection geometry is incorrect.

Toyota Sienna Hybrid Recall 2025 Over Third-Row Seatback Bolts

Alphatec Spine Recalls Lateral Navigation Disc Prep Instruments Due to Design Flaw

Due a design issue where the navigated array connection geometry is incorrect.

Kia Recalled 2025 Sorento Hybrid and 2024-2025 Sorento SUVs for BDC Software Issue

Miach Orthopaedics Recalls BEAR Implant Over Expiration Date Error

Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.

Medline Industries Recalls IV Administration Sets Due to Leakage Risk

Medica Recalls Capillary Tube Kit Over False Potassium Readings

Medica recalled 1,578 units of its Capillary Tubes on December 31, 2025. A systematic positive bias of up to 20% can produce false elevation results in patient potassium levels. Healthcare providers and patients must stop using the device immediately.

Wizcure Pharmaa Recalls Ophthalmic Strips Over Sterility Concerns

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Wizcure Pharmaa Recalls Eye Drops Due to Sterility Risk

Wizcure Pharmaa PVT. LTD. recalled 11,520 cartons of Vista Meibo Tears Eye Drops on December 31, 2025. The recall occurred due to lack of assurance of sterility, posing a high risk to consumers. The affected product was distributed nationwide in the USA.

Alvogen Recalls Levothyroxine Sodium Tablets Due to Mix-Up

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.