Estados Unidos Recalls

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.

Ajinomoto Foods North America Inc.

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.

Apr 1, 2026Ajinomoto Foods North America Inc.

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.

Ajinomoto Foods North America 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.

Apr 1, 2026Ajinomoto Foods North America 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.

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

Apr 1, 2026Philips Ultrasound, Inc

Philips L12-5 Ultrasound Transducer

Philips Ultrasound, Inc

FDA DevicesClass III

Philips L12-5 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

King Harvest brand Black Olive Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Black Olive Hummus 10 oz. UPC 025726 311216

Pacific Coast Fresh CO

Apr 1, 2026Pacific Coast Fresh CO

King Harvest brand Black Olive Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Black Olive Hummus 10 oz. UPC 025726 311216

Foreign material (aluminum pieces).

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

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

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

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.

Apr 1, 2026Olympus 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.

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.

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. GmbH

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).

Apr 1, 2026I.T.S. GmbH

Olympus Corporation of the Americas

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

Apr 1, 2026Olympus Corporation of the Americas

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

Slow Roasted Diced Tomatoes (SKU 900, UPC 00823338009008). Frozen. Shelf life: 365 days (frozen) from date of manufacture; 30 days (refrigerated, unopened); 7 days (refrigerated, opened). Plastic poly liner inside cardboard box (bulk). Net weight: 24 lbs. Firm: Sevillo Fine Foods, Salt Lake City UT, 84115.

Sevillo Fine Foods, Inc

Apr 1, 2026Sevillo Fine Foods, Inc

Slow Roasted Diced Tomatoes (SKU 900, UPC 00823338009008). Frozen. Shelf life: 365 days (frozen) from date of manufacture; 30 days (refrigerated, unopened); 7 days (refrigerated, opened). Plastic poly liner inside cardboard box (bulk). Net weight: 24 lbs. Firm: Sevillo Fine Foods, Salt Lake City UT, 84115.

Product may contain foreign material (metal fragments).

Teva Pharmaceuticals USA, Inc

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08.

Apr 1, 2026Teva Pharmaceuticals USA, Inc

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08.

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arlington, VA 22202. Product of Germany.

Lidl US TRADING

Apr 1, 2026Lidl US TRADING

Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arlington, VA 22202. Product of Germany.

Label does not specify type of tree nut contained in the product.

American Laboratories, LLC

Pepsin 1:10,000 Powder, 10 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.

Apr 1, 2026American Laboratories, LLC

Pepsin 1:10,000 Powder, 10 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.

Potential Salmonella contamination.

Tops GOLD Green Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288612837 INGREDIENTS:Mustard Oil

Mangalm LLC

Tops GOLD Green Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288612837 INGREDIENTS:Mustard Oil

Potential adulteration with erucic acid from mustard oil ingredient.

Apr 1, 2026Mangalm LLC

Tops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENTS:Mustard Oil

Mangalm LLC

Tops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENTS:Mustard Oil

Potential adulteration with erucic acid from mustard oil ingredient.

Apr 1, 2026Mangalm LLC

Ajinomoto Foods North America Inc.

Item 6430093 Ajinomoto Green Gyoza Vegetable & Edamame Dumplings 12ct. Retail bag UPC: None. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/12ct. bags per case. Case UPC 10071757080246. All products are intended to be stored frozen and fully cooked to 165F before eating.

Apr 1, 2026Ajinomoto Foods North America Inc.

Item 6430093 Ajinomoto Green Gyoza Vegetable & Edamame Dumplings 12ct. Retail bag UPC: None. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/12ct. bags per case. Case UPC 10071757080246. 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.

Teva Pharmaceuticals USA, Inc

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.

Apr 1, 2026Teva Pharmaceuticals USA, Inc

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System

Orthalign, Inc

Apr 1, 2026Orthalign, Inc

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System

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

I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

I.T.S. GmbH

I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

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

Apr 1, 2026I.T.S. GmbH

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.

Chiesi USA, Inc.

Apr 1, 2026Chiesi USA, Inc.

CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.

Lack of Assurance of Sterility

Teva Pharmaceuticals USA, Inc

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.

Apr 1, 2026Teva Pharmaceuticals USA, Inc

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

American Laboratories, LLC

Pepsin Full Strength Powder, 50 kg, Item #5000545, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.