Food
Class I
Ongoing
Reported Aug 19, 2026
Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-60902 1. Distributed by The Kroge...
Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-60902 1. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Kroger, Medium, 30 Eggs, Net Wt 52.5 oz (3lb 4.5oz) 596g, UPC 0 11110-60980 9. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Kroger, Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-60903 8. Distributed by The Kroger Co., Cincinnati, OH 45202. 4. Kroger, Large 18 Eggs, Net Wt 36 oz (2lb 4oz...
- Firm
- MIDWEST POULTRY SERVC C/O H & LELECTRIC
- Codes
- Code information is printed on the left or right sides of the carton. Codes P-1950 or 0840962 with a Julian Date between 157 and 184 and a Best By/Sell By date Between July 20 - Au...
- Reason
- Possible Salmonella Enteritidis
Food
Class I
Ongoing
Reported Aug 19, 2026
Dark Chocolate Coconut Almond Bites, 3.17oz, Plastic Pouches, 10 Packages per case.
Dark Chocolate Coconut Almond Bites, 3.17oz, Plastic Pouches, 10 Packages per case.
- Firm
- Bazzini LLC
- Codes
- B15354, B15356, B15357, B15360, B15361, B15363
- Reason
- Undeclared peanuts
Food
Class I
Ongoing
Reported Aug 19, 2026
Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage Free Grain Fed, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 1111...
Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage Free Grain Fed, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-87032 0. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Simple Truth, Natural Cage Free Grain Fed, Large, 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-79770 4. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Simple Truth, Natural Cage Free Grain Fed, Large, 18 Eggs, Net Wt 36 oz (2lb 4oz) 1,031g, UPC 0 11110-89310...
- Firm
- MIDWEST POULTRY SERVC C/O H & LELECTRIC
- Codes
- Code information is printed on the left or right sides of the carton. Codes P-1950 or 0840962 with a Julian Date between 157 and 184 and a Best By/Sell By date Between July 20 - Au...
- Reason
- Possible Salmonella Enteritidis
Drugs
Class I
Ongoing
Reported Aug 19, 2026
Kian Pee Wan Capsules, 30-count bottles
Kian Pee Wan Capsules, 30-count bottles
- Firm
- Buy-Herbal
- Codes
- All lots within expiry.
- Reason
- Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Drugs
Class I
Ongoing
Reported Aug 19, 2026
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VM...
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.
- Firm
- Victory Medical Center Pharmacy
- Codes
- Lot # 1984345, 1980571, 1981940, Use Before Date: 08/27/2026.
- Reason
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Drugs
Class I
Ongoing
Reported Aug 19, 2026
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarshei...
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
- Firm
- Liebel-Flarsheim Company LLC
- Codes
- Lot # 25ZF3670, Exp Date: May 31, 2027.
- Reason
- Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Devices
Class I
Ongoing
Reported Aug 19, 2026
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing sy...
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
- Firm
- Spectra Medical Devices, Llc
- Codes
- Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, A...
- Reason
- Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganism...
Food
Class I
Ongoing
Reported Aug 12, 2026
Selectos Latinos Requeson Mexicano Mexican Cottage Cheese, Net Weight 16 oz, packed into retail-sized clear plastic containers. Keep refrigerated.
Selectos Latinos Requeson Mexicano Mexican Cottage Cheese, Net Weight 16 oz, packed into retail-sized clear plastic containers. Keep refrigerated.
- Firm
- La Colonia Foods Llc
- Codes
- Selec1011
- Reason
- Products may be contaminated with Listeria monocytogenes.
Food
Class I
Ongoing
Reported Aug 12, 2026
Clover Hill Dairy LLP, mild cheese variety (Snack Pack Assorted Regular Mild Stix White Colby, Marble Jack, Yummy Cheddar). Sold in approximate 0.40-lb (6.4oz) units. Unknown infor...
Clover Hill Dairy LLP, mild cheese variety (Snack Pack Assorted Regular Mild Stix White Colby, Marble Jack, Yummy Cheddar). Sold in approximate 0.40-lb (6.4oz) units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
- Firm
- Clover Hill Dairy, LLC
- Codes
- AA051526
- Reason
- Product contaminated with Listeria monocytogenes.
Food
Class I
Ongoing
Reported Aug 12, 2026
Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy Breakfast Burrito Net Wt. 8.2 oz (232g) UPC 1 00001 00029 7 and Sprig & Sprout Spicy Breakfa...
Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy Breakfast Burrito Net Wt. 8.2 oz (232g) UPC 1 00001 00029 7 and Sprig & Sprout Spicy Breakfast Burrito IN A SPICY TORTILLA NET WEIGHT 8.3oz (234g) Contains: Egg, Milk, Wheat. MG Foods Charlotte, NC 28272
- Firm
- M.G. Foods, Inc.
- Codes
- Fresh Thru: 07/20/26
- Reason
- Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
Food
Class I
Ongoing
Reported Aug 12, 2026
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habanero Peppers). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb...
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habanero Peppers). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
- Firm
- Clover Hill Dairy, LLC
- Codes
- AA051526
- Reason
- Product contaminated with Listeria monocytogenes.
Food
Class I
Ongoing
Reported Aug 12, 2026
Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle. Intended Use: take 2 capsules per day. Route of Administration: Or...
Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle. Intended Use: take 2 capsules per day. Route of Administration: OraI. Manufactured for Zen Principle 774 Mays Blvd Incline Village, NV 89451. The product is offered as a 1-pack (180 capsules; Amazon code/FNSKU X000ZJJ4FT) and as a 2-pack (twin pack, 360 capsules; Amazon code/FNSKU X00159YJXP).
- Firm
- FACTORY6, INC.
- Codes
- LOT: A6FF4, Best By: 11/2028
- Reason
- Possible Salmonella in Moringa Leaf Powder product.
Food
Class I
Ongoing
Reported Aug 12, 2026
Clover Hill Dairy LLP, Mild Cheese Variety (Yummy Cheddar, White Cheddar, White Colby, Monterey Jack, Marble Jack). Sold in 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown inf...
Clover Hill Dairy LLP, Mild Cheese Variety (Yummy Cheddar, White Cheddar, White Colby, Monterey Jack, Marble Jack). Sold in 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
- Firm
- Clover Hill Dairy, LLC
- Codes
- AA051526
- Reason
- Product contaminated with Listeria monocytogenes.
Food
Class II
Ongoing
Reported Aug 19, 2026
Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.
Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.
- Firm
- SHEANDRO LLC
- Codes
- Lot Code: LZ1 R169 Expiration Date (s): 06/30/2028
- Reason
- Label declares cream and cheese, but Milk is not declared
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Ino...
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
- Firm
- Shoolin Pharma Chem LLP
- Codes
- Batch SDC2505001, Date of Expiry: April 30, 2030.
- Reason
- CGMP Deviations:Noted during FDA inspection
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65...
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01
- Firm
- Apollo Care, LLC
- Codes
- Lot: AC-017273, Exp. 12/12/2026.
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05
- Firm
- Apollo Care, LLC
- Codes
- Lot: AC-017108, Exp. 11/17/2026; AC-017110, Exp. 11/20/2026; AC-017112, Exp. 11/21/2026; AC-017142, AC-017144, Exp. 12/10/2026; AC-017166, AC-017167, AC-017177, AC-017213, AC-01722...
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
- Firm
- Apollo Care, LLC
- Codes
- Lot: AC-017114, Exp. 11/24/2026; AC-017164, AC-017204, AC-017205, Exp. 12/31/2026.
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drugs
Class II
Ongoing
Reported Aug 19, 2026
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
- Firm
- Heritage Pharmaceuticals Inc
- Codes
- Lot #: 2411550, Exp. 2026/NOV.
- Reason
- Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65...
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
- Firm
- Apollo Care, LLC
- Codes
- Lot: AC-017271, Exp. 12/12/2026.
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01
- Firm
- Apollo Care, LLC
- Codes
- Lot: C-017115, Exp. 11/25/2026; AC-017163, Exp. 12/31/2026; AC-017169, AC-017170, AC-017171, Exp. 12/31/2026; AC-017230, AC-017231, Exp. 5/5/2027.
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
- Firm
- Apollo Care, LLC
- Codes
- Lot: AC-017131, Exp. 8/30/2026.
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Drugs
Class II
Ongoing
Reported Aug 19, 2026
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC...
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
- Firm
- Prestige Brands Holdings
- Codes
- Lot 2552A, Exp 09/30/2027
- Reason
- Lack of assurance of sterility. The recall is due to potential contamination
Devices
Class II
Ongoing
Reported Aug 19, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b...
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
- Firm
- W L Gore & Associates, Inc.
- Codes
- Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN101...
- Reason
- 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Devices
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog...
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KI...
- Firm
- Cardinal Health 200, LLC
- Codes
- 1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A,...
- Reason
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Devices
Class II
Ongoing
Reported Aug 19, 2026
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPAS...
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX...
- Firm
- Covidien, LP
- Codes
- BOX06614V4 UDI-DI 00199150037902 Lots 0233506453 0233506454 0233506455 0233506456 BOX07405V1 UDI-DI 00763000960186 Lot 0233617676 BOX01056V2 UDI-DI 00763000593711 Lot 0233484641 BO...
- Reason
- Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v...
Devices
Class II
Ongoing
Reported Aug 19, 2026
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter int...
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
- Firm
- MICROVENTION INC.
- Codes
- Catalog Number: BOB-895-CN UDI codes: (01)00842429111062(11)250819(17)280731(10)0001218734 (01)00842429111062(11)250822(17)280731(10)0001222844 (01)00842429111062(11)250825(17)2807...
- Reason
- Due to an increase rate of balloon pinhole defects.
Devices
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
- Firm
- Cardinal Health 200, LLC
- Codes
- 1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot...
- Reason
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Devices
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
- Firm
- Medline Industries, LP
- Codes
- UDI-DI (each) 00193489015242, UDI-DI (case) 20193489015246, Lot Numbers: All lots produced between 05/27/2025 and 04/10/2026
- Reason
- Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life....
Devices
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN3...
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMIN...
- Firm
- Cardinal Health 200, LLC
- Codes
- 1) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 2) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 3) P...
- Reason
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Devices
Class II
Ongoing
Reported Aug 19, 2026
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Codes
- Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)0088...
- Reason
- Firmware issue potentially leading to loss of geometry movements.
Devices
Class II
Ongoing
Reported Aug 19, 2026
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial...
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
- Firm
- Terumo Medical Corporation
- Codes
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- Reason
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Devices
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
- Firm
- Medline Industries, LP
- Codes
- UDI-DI (each) 80080196314521, UDI-DI (case) 10080196314522, Lot Numbers: All lots produced between 10/27/2025 and 11/19/2025
- Reason
- Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life....
Devices
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
- Firm
- Medline Industries, LP
- Codes
- UDI-DI (each) 10888277652521, UDI-DI (case) 20888277652528, Lot Numbers: All lots produced between 05/13/2025 and 04/21/2026
- Reason
- Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life....
Food
Not Yet Classified
Ongoing
Reported Aug 19, 2026
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
- Firm
- Taylor Farms de Mexico S. de R.L. de C.V.
- Codes
- MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# TFMX183A05 7/21/2026 TFMX184A02 7/22/2026 TFMX187B02 7/25/2026 TFMX189A03 7/27/2026 TFMX190A03 7/28/2026 TFMX190B01 7/28/2026 TFMX...
- Reason
- Potential Cyclospora contamination.
Food
Class III
Ongoing
Reported Aug 19, 2026
Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 91730
Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 91730
- Firm
- FlavorsandColor.Com
- Codes
- Lot: 60609-8 EXP: 06/08/28
- Reason
- Undeclared Red #40.