Safety Recall Directory

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

Straumann USA LLC

Apr 1, 2026Straumann USA LLC

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Orthalign, Inc

Apr 1, 2026Orthalign, Inc

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Beckman Coulter, Inc.

Apr 1, 2026Beckman Coulter, Inc.

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Due to the likely presence of contamination in well(s).

Philips Respironics, Inc.

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

FDA DevicesClass I

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

Apr 1, 2026Philips Respironics, Inc.

Olympus Corporation of the Americas

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Apr 1, 2026Olympus Corporation of the Americas

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

Koven Technology, Inc.

Apr 1, 2026Koven Technology, Inc.

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic butter sauce. There are 6/9oz. bags per box or 54oz per box. Retail box UPC 071757508835. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/54oz boxes or 27lb. per case. Case UPC 10071757508832. All products are intended to be stored frozen and fully cooked to 165F before eating.

Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic butter sauce. There are 6/9oz. bags per box or 54oz per box. Retail box UPC 071757508835. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/54oz boxes or 27lb. per case. Case UPC 10071757508832. All products are intended to be stored frozen and fully cooked to 165F before eating.

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UPC 00979085. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 24/1lb. bags per case. Case UPC 10097908500001. All products are intended to be stored frozen and fully cooked to 165F before eating.

Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097908. Net wt. 1lb. per bag. Retail bag UPC 00979085. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 24/1lb. bags per case. Case UPC 10097908500001. All products are intended to be stored frozen and fully cooked to 165F before eating.

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Olympus Corporation of the Americas

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Apr 1, 2026Olympus Corporation of the Americas

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per bag. Retail bag UPC 076366565439. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/3lb. bags or 12 lbs. per case. Case UPC 10076366565436. All products are intended to be stored frozen and fully cooked to 165F before eating.

Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per bag. Retail bag UPC 076366565439. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/3lb. bags or 12 lbs. per case. Case UPC 10076366565436. All products are intended to be stored frozen and fully cooked to 165F before eating.

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

Roasted Tomato Parmesan Focaccia Bread sold under the brand names of FREDERIK'S by meijer SLOW-ROASTED TOMATO & SHREDDED PARMESAN CHEESE NET WT 13.75 OZ (390g) UPC 7 13733 88387 0 DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544; fresh & simple Roasted Tomato & Parmesan Focaccia NET WT. 13.75 oz (390g) UPC 8 50061 35318 4 Distributed By: Bakkavor Foods USA Inc., Charlotte, NC 28273; HT Traders Roasted Tomato & Parmesan FOCACCIA NET WT. 13.75 oz (390g) UPC 0 72036 95631 6 PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 TRADER JOE'S FOCACCIA BREAD Roasted Tomato & Parmesan NET WT. 14 OZ (397g) UPC 0064 4358 DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016

Bakkavor

Roasted Tomato Parmesan Focaccia Bread sold under the brand names of FREDERIK'S by meijer SLOW-ROASTED TOMATO & SHREDDED PARMESAN CHEESE NET WT 13.75 OZ (390g) UPC 7 13733 88387 0 DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544; fresh & simple Roasted Tomato & Parmesan Focaccia NET WT. 13.75 oz (390g) UPC 8 50061 35318 4 Distributed By: Bakkavor Foods USA Inc., Charlotte, NC 28273; HT Traders Roasted Tomato & Parmesan FOCACCIA NET WT. 13.75 oz (390g) UPC 0 72036 95631 6 PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 TRADER JOE'S FOCACCIA BREAD Roasted Tomato & Parmesan NET WT. 14 OZ (397g) UPC 0064 4358 DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016

Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.

Apr 1, 2026Bakkavor

Savannah Bee Company Inc.

SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, SPICES (INCLUDING PAPRIKA AND TUMERIC), NATURAL FLAVOR, GARLIC), HONEY, WATER, DISTILLED VINEGAR, SUGAR, TOMATO CONCENTRATE, HABANERO PEPPERS, GARLIC, SPICES, SALT, ONION, POTASSIUM SORBATE, SODIUM BENZOATE, NATURAL FLAVOR UPC 8 50033 93758 9 BOTTLED BY: BOBBEES FOR SAVANNAH BEE COMPANY 211 JONNY MERCER BLVD, SAVANNAH, GA 31410

Apr 1, 2026Savannah Bee Company Inc.

SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, SPICES (INCLUDING PAPRIKA AND TUMERIC), NATURAL FLAVOR, GARLIC), HONEY, WATER, DISTILLED VINEGAR, SUGAR, TOMATO CONCENTRATE, HABANERO PEPPERS, GARLIC, SPICES, SALT, ONION, POTASSIUM SORBATE, SODIUM BENZOATE, NATURAL FLAVOR UPC 8 50033 93758 9 BOTTLED BY: BOBBEES FOR SAVANNAH BEE COMPANY 211 JONNY MERCER BLVD, SAVANNAH, GA 31410

Undeclared Allergens: Soy & Wheat. The firm was notified by a customer that the product is labeled as Savannah Bee Company Honey BBQ Sauce "Mustard", but the product inside the bottle is a different flavor of BBQ sauce. After investigation, the firm determined that the product in the bottle is their Honey BBQ Sauce "Sweet". The BBQ sauce "Sweet" contains wheat and soy which is not listed on the BBQ Sauce "Mustard" label.

Distribuidora de Alimentos Sendero LLC

Gorditas de Azucar UPC 860010238134

FDA FoodClass I

Gorditas de Azucar UPC 860010238134

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

Apr 1, 2026Distribuidora de Alimentos Sendero LLC

Tops GOLD Mango Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611373 INGREDIENTS:Mustard Oil Tops GOLD Mango Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288611915; 8904288613025 INGREDIENTS:Mustard Oil

Mangalm LLC

Tops GOLD Mango Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611373 INGREDIENTS:Mustard Oil Tops GOLD Mango Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288611915; 8904288613025 INGREDIENTS:Mustard Oil

Potential adulteration with erucic acid from mustard oil ingredient.

Apr 1, 2026Mangalm LLC

Merit Medical Systems, Inc.

16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

FDA DevicesClass I

16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Apr 1, 2026Merit Medical Systems, Inc.

Item 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of long grain rice assorted vegetables & egg. Net wt. 22oz. Retail box UPC 011110041623. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/22oz. boxes or 8.25 lbs. per case. Case UPC 10011110041620. All products are intended to be stored frozen and fully cooked to 165F before eating.

Item 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of long grain rice assorted vegetables & egg. Net wt. 22oz. Retail box UPC 011110041623. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/22oz. boxes or 8.25 lbs. per case. Case UPC 10011110041620. All products are intended to be stored frozen and fully cooked to 165F before eating.

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Tops GOLD Khatta Meetha Pickle NET QTY.: 33.51oz PRODUCT OF INDIA UPC: 8904288611427 INGREDIENTS:Mustard Oil

Mangalm LLC

Tops GOLD Khatta Meetha Pickle NET QTY.: 33.51oz PRODUCT OF INDIA UPC: 8904288611427 INGREDIENTS:Mustard Oil

Potential adulteration with erucic acid from mustard oil ingredient.

Apr 1, 2026Mangalm LLC

NRS Enterprises, Inc. dba Sunflour Bakery

Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522

Apr 1, 2026NRS Enterprises, Inc. dba Sunflour Bakery

Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522

Undeclared sesame seed ingredient in hamburger buns.

Olympus Corporation of the Americas

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.