Safety Recall Directory

Ajinomoto Foods North America Inc.

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.

Apr 1, 2026Ajinomoto Foods North America Inc.

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

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

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.

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

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).

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

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

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 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.

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.

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).

Merit Medical Systems, Inc.

ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C

FDA DevicesClass I

ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C

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.

Pharmaceutical

FDA Drugs

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

MACLEODS PHARMA USA, INC

FDA DrugsClass II

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

Subpotent Drug

Apr 1, 2026MACLEODS PHARMA USA, INC

Olympus Corporation of the Americas

Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK 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 w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK 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.

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

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

Merit Medical Systems, Inc.

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D

FDA DevicesClass I

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D

Apr 1, 2026Merit Medical Systems, Inc.

Ajinomoto Foods North America Inc.

Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box. Retail box UPC 070077811465. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/48oz. boxes or 12lbs. per case. Case UPC 10070077811462. All products are intended to be stored frozen and fully cooked to 165F before eating.

Apr 1, 2026Ajinomoto Foods North America Inc.

Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box. Retail box UPC 070077811465. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/48oz. boxes or 12lbs. per case. Case UPC 10070077811462. 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

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35

Radnostix

FDA DrugsClass III

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35

Failed Tablet/Capsule Specifications

Apr 1, 2026Radnostix

MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

Medtronic MiniMed, Inc.

Apr 1, 2026Medtronic MiniMed, Inc.

MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

Pharmaceutical

FDA Drugs

Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.

Amerisource Health Services LLC

FDA DrugsClass II

Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.

Failed tablet specifications.

Apr 1, 2026Amerisource Health Services LLC

Ajinomoto Foods North America Inc.

Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/8.92oz. packages or 11.15 lbs. per case. Carton UPC 10071757055480. All products are intended to be stored frozen and fully cooked to 165F before eating.

Apr 1, 2026Ajinomoto Foods North America Inc.

Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/8.92oz. packages or 11.15 lbs. per case. Carton UPC 10071757055480. 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.