États-Unis Recalls

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.

I.T.S. GmbH

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).

Apr 1, 2026I.T.S. GmbH

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 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.

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

Erbe USA Inc

FDA DevicesClass I

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

Probes may rupture/burst during activation

Apr 1, 2026Erbe USA Inc

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

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 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.

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.

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

I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

I.T.S. GmbH

I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

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

Waldemar Link GmbH & Co. KG (Mfg Site)

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Apr 1, 2026Waldemar Link GmbH & Co. KG (Mfg Site)

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

I.T.S. GmbH

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

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

Apr 1, 2026Philips Ultrasound, Inc

Philips 3D6-2 Ultrasound Transducer

Philips Ultrasound, Inc

FDA DevicesClass III

Philips 3D6-2 Ultrasound Transducer

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

Apr 1, 2026Philips Ultrasound, Inc

Philips C9-4 Ultrasound Transducer

Philips Ultrasound, Inc

FDA DevicesClass III

Philips C9-4 Ultrasound Transducer

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

Pan de Bono (Cheese Bread), 100 units per Paper Cardboard Box, Net Wt 14.4 lb. KEEP FROZEN

South Florida Food, LLC

Apr 1, 2026South Florida Food, LLC

Pan de Bono (Cheese Bread), 100 units per Paper Cardboard Box, Net Wt 14.4 lb. KEEP FROZEN

Undeclared Soy.

Philips Respironics, Inc.

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

FDA DevicesClass I

Philips Respironics Trilogy Evo O2, 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.

Pharmaceutical

FDA Drugs

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.

Teva Pharmaceuticals USA, Inc

FDA DrugsClass II

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.

Apr 1, 2026Teva Pharmaceuticals USA, Inc

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

Ajinomoto Foods North America Inc.

Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried Rice with Edamame, Carrots, Fire Roasted Corn & Red Bell Peppers Prepared with Sweet Soy Sauce Infused Rice. Net wt. 17oz. Retail box UPC 010878810915. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/17oz. boxes per case. Case UPC 10010878810912. All products are intended to be stored frozen and fully cooked to 165F before eating.

Apr 1, 2026Ajinomoto Foods North America Inc.

Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried Rice with Edamame, Carrots, Fire Roasted Corn & Red Bell Peppers Prepared with Sweet Soy Sauce Infused Rice. Net wt. 17oz. Retail box UPC 010878810915. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/17oz. boxes per case. Case UPC 10010878810912. 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.

Pharmaceutical

FDA Drugs

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.

Teva Pharmaceuticals USA, Inc

FDA DrugsClass II

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.

Apr 1, 2026Teva Pharmaceuticals USA, Inc

American Laboratories, LLC

Pepsin 1:3000 Powder, 50 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 1:3000 Powder, 50 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.

King Harvest brand Roasted Red Pepper Hummus. Product is packed in 10 and 17 oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Roasted Red Pepper Hummus 10 oz. UPC 025726 311278 Roasted Red Pepper Hummus 17 oz. UPC 025726 311261

Pacific Coast Fresh CO

Apr 1, 2026Pacific Coast Fresh CO

King Harvest brand Roasted Red Pepper Hummus. Product is packed in 10 and 17 oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Roasted Red Pepper Hummus 10 oz. UPC 025726 311278 Roasted Red Pepper Hummus 17 oz. UPC 025726 311261

Foreign material (aluminum pieces).

AMO Puerto Rico Manufacturing, Inc.

Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

Apr 1, 2026AMO Puerto Rico Manufacturing, Inc.

Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.

Ajinomoto Foods North America Inc.

Item 5650893 Ajinomoto Japanese-Style Vegetable Fried Rice made with hijiki seaweed, fried tofu, edamame, and other colorful vegetables in an umami dashi sauce Net wt. 17oz. Retail box UPC 071757508934. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/17oz. boxes or 8.5 lbs. per case. Case UPC 10071757508931. All products are intended to be stored frozen and fully cooked to 165F before eating.