Michigan recalls

Olympus has recalled the Glass Body for the 194 Ellik Evacuator (Model 190A) because some sterilization instructions in the user manual may not reliably make the device sterile. The affected sterilization parameters should no longer be used.

Olympus has recalled the Ellik Evacuator (Model 194), a medical device used during urological procedures. Some sterilization methods described in the device instructions may not reliably sterilize the device, creating a potential infection risk.

Olympus has recalled the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization instructions in the product manual may not reliably make the device fully sterile. Affected units were distributed worldwide, including across the US, Canada, Japan, Europe, and Latin America.

Olympus has recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because some of the sterilization instructions in the device manual may not reliably make the device sterile. The affected instructions should no longer be used.

Argon Medical Devices is recalling bone marrow tray kits (models CB0033TL and CB0355TLA) that contain lidocaine injections. The lidocaine ampules in these kits did not meet sterility standards required for safe use. The kits were distributed nationwide and internationally.

Argon Medical Devices is recalling certain Arterial Line Kits (model 20ga x 6, REF: 400115A) that contain Lidocaine HCL Injection. These kits failed sterility testing and do not meet safety release criteria. The affected kits have specific lot numbers with expiration dates in July 2027.

Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits that contain Lidocaine HCL Injection ampules. These kits failed to meet sterility standards during quality testing. The affected kits were distributed nationwide and internationally.

Argon Medical Devices is recalling General Biopsy Trays (REF: GUTS1000) that contain Lidocaine HCL Injection ampules. The lidocaine ampules in these kits did not meet sterility release criteria, meaning they may not be safe for use. Approximately 1,800 kits were distributed nationwide and to Trinidad and Tobago.

Argon Medical Devices is recalling One-Piece Introducer Trays (REF 497455 and 497434) that contain Lidocaine HCL Injection ampules. The Lidocaine ampules in these kits did not meet sterility release criteria, meaning they were not verified as free from contamination before distribution.

Argon Medical Devices is recalling certain transvenous pacing electrode trays (model 008416A and 008566A) because they contain lidocaine ampules that did not meet sterility standards. The affected kits were distributed nationwide and internationally. No injuries have been reported.

Abiomed heart pump introducer sheaths in the Intro Kit may leak fluid from under the sheath cap or along the hub score lines. The manufacturing defect is not visible to users. All current batches of the kit worldwide are affected.

Abiomed has recalled the Impella CP heart pump due to a potential for fluid leakage from the introducer sheath (a tube inserted during the procedure). The leakage can occur under the sheath cap or along connection points, and these defects cannot be seen by the user. All current batches of the pump set are affected worldwide.

Abiomed has recalled its Impella CP Smart Assist Set heart pump due to a potential leak in the introducer sheath (a thin tube used during insertion). The leak can occur under the sheath cap or along seam lines in certain models, but the defect is not visible to the user. All current batches worldwide are affected.

Abiomed has recalled the Impella CP heart pump set due to a manufacturing defect in the introducer sheath that can cause leakage. The leakage can occur under the sheath cap or along hub score lines in the 14Fr and 23Fr introducers included with every pump set, and the defect is not visible to users.

Abiomed has recalled certain Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a manufacturing defect in the introducer sheaths. The 14Fr and 23Fr introducers included in these pump sets may leak fluid from under the sheath cap or along hub seams, and the leakage cannot be seen by the user before or during use.

The Abiomed Impella 5.5 Smart Assist Set heart pump contains an introducer sheath that may leak under the cap or along hub seams. This manufacturing defect is not visible to the user but is present in all affected pump sets. The issue affects 383 units distributed worldwide.

Abiomed has recalled certain Introducer Kit 23 Fr units (Pump Set Code 1000441) due to a potential for sheath leakage from under the sheath cap and along hub score lines. This manufacturing issue cannot be seen by the user and affects introducers included in every pump set.

Abiomed has recalled the Impella CP Introducer Kit (Pump Set Code 1000550) worldwide due to a potential for fluid leakage from under the sheath cap and along hub score lines in the 14Fr and 23Fr introducers. The leakage defect is not visible to the user and affects all current batches of this heart pump accessory kit.

Abiomed has recalled the Impella CP heart pump introducer due to a manufacturing defect that can cause fluid leakage from under the sheath cap and along the hub. The defect is not visible to the user and affects all current batches worldwide.

The Abiomed Impella RP Flex heart pump set includes introducers that may leak fluid from under the sheath cap or along hub score lines due to manufacturing defects. These leaks cannot be seen by visual inspection. All current batches worldwide are affected.

Amy's Kitchen organic lentil soup (light in sodium, 14.5 oz cans) with lot code 60D0924 and best-before date of April 2027 may spoil before the printed date. The affected product was distributed across the U.S. and Canada.

Nutricia North America discovered that its testing laboratory used an incorrect method to measure vitamin A content in NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY. The test results showed higher vitamin A levels than what is actually in the product, meaning affected packages contain less vitamin A than the label states.

Nutricia North America discovered that its testing lab used an incorrect method to measure Vitamin A in Liquid Hope Organic Whole Foods Meal Replacement Peptide Formula (Berry Medley). As a result, the product contains less Vitamin A than the label states. The affected pouches have best-if-used-by dates through March 15, 2028 (24-count cases) and October 7, 2027 (12-count packages).

BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, may have open or incomplete seals on individual applicator packaging. This could allow contamination of the sterile product. The issue affects multiple lot numbers distributed nationwide.

Chiesi USA is recalling specific lots of CLEVIPREX (clevidipine) injectable emulsion because the manufacturer cannot guarantee the vials are sterile. This affects vials distributed nationwide with lot numbers 1239521 and 1237454, expiring in October 2027. No injuries have been reported.

CAREone Carbamide Peroxide 6.5% oral rinse (lot 1505141, expiring April 2027) contains significantly less active ingredient than labeled (~0.6% instead of ~6.5%) and has a lower pH than specified. The product may not work as intended for its intended use.

Meijer's Carbamide Peroxide 6.5% oral rinse (0.5 FL OZ, lot 1505344, expiration April 2027) contains significantly less active ingredient than labeled — approximately 0.6% instead of the expected 6–7%. The product also has a lower pH than specified. This means the rinse will not work as intended for oral care.

Foster & Thrive Carbamide Peroxide 6.5% oral rinse was found to contain significantly less active ingredient than labeled (~0.6% instead of ~6-7%), along with abnormally low pH. The affected product may not work as intended for its intended use. No injuries have been reported.

Some bottles and kits of Leader Carbamide Peroxide 6.5% contain significantly less active ingredient than labeled (about 0.6% instead of 6–7%) and have an abnormally low pH. The product may not work as intended for ear wax removal or oral rinse.

Good Neighbor Pharmacy Carbamide Peroxide 6.5% ear-cleaning solution was distributed with significantly reduced active ingredient (~0.6% instead of ~6–7%) and abnormal pH. The product may not work as intended for ear wax removal.