Drugs
Class II
Ongoing
Reported Sep 2, 2026
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc....
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
- Firm
- Hikma Pharmaceuticals USA INC.
- Codes
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- Reason
- Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Food
Class II
Ongoing
Reported Sep 2, 2026
Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
- Firm
- Dreyer's Grand Ice Cream Inc.
- Codes
- Batch code/ Best Before (bottom of package): LLA616903 30 SEP 2027 LLA617003 30 SEP 2027 LLA617103 30 SEP 2027 LLA617203 30 SEP 2027 LLA617303 30 SEP 2027 LLA617403 30 SEP 2027 LLA...
- Reason
- Foreign object: products may contain glass pieces
Food
Class II
Ongoing
Reported Sep 2, 2026
Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
- Firm
- Dreyer's Grand Ice Cream Inc.
- Codes
- Batch code/ Best Before (bottom of package): LLA617603 30 JUN 2027 LLA617703 30 JUN 2027 LLA617803 30 JUN 2027 LLA617903 30 JUN 2027 LLA618003 30 JUN 2027 LLA618103 30 JUN 2027 LLA...
- Reason
- Foreign object: products may contain glass pieces
Food
Class II
Ongoing
Reported Sep 2, 2026
Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
- Firm
- Dreyer's Grand Ice Cream Inc.
- Codes
- Batch code/ Best Before (bottom of package): LLA616803 30 SEP 2027 LLA616903 30 SEP 2027 LLA619703 31 OCT 2027 UPC Bottom of package: 041548244044 LLA619803 31 OCT 2027 LLA619903 3...
- Reason
- Foreign object: products may contain glass pieces
Food
Class II
Ongoing
Reported Sep 2, 2026
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
- Firm
- Dreyer's Grand Ice Cream Inc.
- Codes
- Batch code/ Best Before (bottom of package): LLA618503 31 JUL 2027 LLA618603 31 JUL 2027 LLA618703 31 JUL 2027 LLA618803 31 JUL 2027 LLA618903 31 JUL 2027 LLA619003 31 JUL 2027
- Reason
- Foreign object: products may contain glass pieces
Devices
Class II
Ongoing
Reported Sep 2, 2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
- Firm
- Olympus Corporation of the Americas
- Codes
- Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
- Reason
- Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Food
Class II
Ongoing
Reported Sep 2, 2026
Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refrigerated.
Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refrigerated.
- Firm
- CUISINE, KETTLE
- Codes
- Best By/ Use By: 8/22/2026
- Reason
- Product had a presumptive positive test result for Listeria monocytogenes
Food
Class II
Ongoing
Reported Sep 2, 2026
Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
- Firm
- Byron White Formulas, Inc.
- Codes
- Lot Code Format = MMD,DYY: 022,224. 061,424. 092,324. 022,125. 071,825. 112,125. 040,826.
- Reason
- Label does not declare walnuts in English
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing,...
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
- Firm
- Church & Dwight Co., Inc.
- Codes
- Lot # UN52882, Exp Date: 04/30/2028; Lot # UN53431, Exp Date: 06/30/2028; Lot # UN60411, Exp Date: 08/31/2028.
- Reason
- CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Food
Not Yet Classified
Ongoing
Reported Sep 2, 2026
Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICANDO FOODS, LLC ALFREDO HOT SAUCE, Net Weight 8 oz. ***INGREDIENTS: Habenaro Peppers, Garli...
Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICANDO FOODS, LLC ALFREDO HOT SAUCE, Net Weight 8 oz. ***INGREDIENTS: Habenaro Peppers, Garlic, Onions, Water, Distilled 5% White Vinegar, Spices***Manufactured and Packed By Africando Foods, LLC 1121S Gilbert Ct. Iowa City, IA 52240***"
- Firm
- Africando Foods LLC
- Codes
- UPC: 860004527114 AF25296, exp. 10/23/2026 AF25303, exp. 10/30/2026 AF25319, exp. 11/15/2026 AF25333, exp. 11/29/2026 AF25343, exp. 12/09/2026 AF25357, exp. 12/23/2026
- Reason
- Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceutic...
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.
- Firm
- ACCORD HEALTHCARE, INC.
- Codes
- Lot #: D2401927, D2401833, Exp. Date 08/31/2026; D2402551, D2402552, Exp. Date 11/30/2026; D2500220, Exp. Date 12/31/2026; D2500223, Exp. Date 01/31/2027.
- Reason
- Subpotent Drug
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceutica...
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
- Firm
- ACCORD HEALTHCARE, INC.
- Codes
- Lot #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, Exp Date. 11/30/2026.
- Reason
- Subpotent Drug
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceutic...
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17.
- Firm
- ACCORD HEALTHCARE, INC.
- Codes
- Lot #: D2402016, D2402017, Exp. Date 08/31/2026
- Reason
- Subpotent Drug
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuti...
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.
- Firm
- ACCORD HEALTHCARE, INC.
- Codes
- Lot #: D2401983, Exp. Date 08/31/2026; D2402640, D2402641, Exp. Date 11/30/2026; D2500224, Exp. Date 01/31/2027.
- Reason
- Subpotent Drug
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accor...
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
- Firm
- ACCORD HEALTHCARE, INC.
- Codes
- a) Lot # D2402125, D2402126, D2402127, Exp. Date 09/30/2026. b) Lot #: D2402523, D2402524, Exp. Date 11/30/2026.
- Reason
- Subpotent Drug
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceutic...
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
- Firm
- ACCORD HEALTHCARE, INC.
- Codes
- Lot #: D2402195, D2402196, D2402197, Exp. Date 09/30/2026.
- Reason
- Subpotent Drug
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Acc...
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
- Firm
- ACCORD HEALTHCARE, INC.
- Codes
- a) Lot # D2402430, D2402431, Exp Date: 10/31/2026. b) Lot #: D2402432, Exp. Date 10/31/2026; D2500180, Exp. Date 12/31/2026.
- Reason
- Subpotent Drug
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals...
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
- Firm
- ACCORD HEALTHCARE, INC.
- Codes
- Lot #: D2402337, Exp. Date 10/31/2026.
- Reason
- Subpotent Drug
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
- Firm
- Mallinckrodt Hospital Products Inc.
- Codes
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Reason
- Presence of particulate matter: glass and stopper piece
Devices
Class II
Ongoing
Reported Sep 2, 2026
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
- Firm
- IMRIS Imaging Inc
- Codes
- 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
- Reason
- The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This...
Devices
Class II
Ongoing
Reported Sep 2, 2026
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
- Firm
- IMRIS Imaging Inc
- Codes
- 114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462,...
- Reason
- The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This...
Food
Class I
Terminated
Reported Sep 2, 2026
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #...
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105 Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI
- Firm
- H & U Inc. dba Sun Noodle
- Codes
- Production Lot: 1226183 Products will be dated for expiration according to their date of defrost by retailer or distributor in the following format: MM/DD
- Reason
- Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared...
Devices
Class II
Ongoing
Reported Sep 2, 2026
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The syst...
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
- Firm
- Canon Medical System, USA, INC.
- Codes
- Model Number: INFX-8000C/B3 UDI code: Pending SID Number:30101165 Serial Number: B3E2422005 Model Number: INFX-8000F/SG UDI code: Pending SID Number: 30093711 Serial Number: SGC241...
- Reason
- Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Drugs
Class II
Ongoing
Reported Sep 2, 2026
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampu...
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
- Firm
- Lupin Pharmaceuticals Inc.
- Codes
- Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
- Reason
- Failed content uniformity specifications.
Food
Class II
Ongoing
Reported Sep 2, 2026
ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC...
ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125839.
- Firm
- Lidl US TRADING
- Codes
- BEST BEFORE: 10/11/2026 LOT NO: 260315
- Reason
- The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coco...
Food
Class II
Ongoing
Reported Sep 2, 2026
ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g...
ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125846.
- Firm
- Lidl US TRADING
- Codes
- BEST BEFORE: 10/11/2026 LOT NO: 260315
- Reason
- The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coco...
Devices
Class II
Ongoing
Reported Sep 2, 2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- Firm
- Merge Healthcare, Inc.
- Codes
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
- Reason
- Software issue may cause measurements to be displayed inaccurately.
Food
Class I
Ongoing
Reported Sep 2, 2026
Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
- Firm
- KHONG GUAN (HQ)
- Codes
- USE BY: 10/19/2027; 9/22/2027
- Reason
- Undeclared peanuts.
Devices
Class II
Ongoing
Reported Sep 2, 2026
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CI...
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Nu...
- Firm
- Medline Industries, LP
- Codes
- 1) Medline Product Number/SKU HUD78007, UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers; 2) Medline Product Number/SKU HUD78009, UDI/DI Discontinued (each) Disc...
- Reason
- Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,...
Devices
Class II
Ongoing
Reported Sep 2, 2026
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ9...
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.
- Firm
- Medline Industries, LP
- Codes
- Medline Kit SKU CDS982040U, UDI/DI 10198459385421 (each) 40198459385422 (case), Lot Number 26AMC355; Medline Kit SKU DYNJ89608, UDI/DI 10198459279324 (each) 40198459279325 (case),...
- Reason
- Kits contain a potentially contaminated component which were recalled by the manufacturer
Devices
Class II
Ongoing
Reported Sep 2, 2026
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
- Firm
- Medline Industries, LP
- Codes
- Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26FMC710; Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case...
- Reason
- Kits contain a potentially contaminated component which were recalled by the manufacturer
Devices
Class II
Ongoing
Reported Sep 2, 2026
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SK...
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
- Firm
- Medline Industries, LP
- Codes
- Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case)...
- Reason
- Kits contain a potentially contaminated component which were recalled by the manufacturer
Devices
Class II
Ongoing
Reported Sep 2, 2026
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ9034...
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.
- Firm
- Medline Industries, LP
- Codes
- Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25LMF531; Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case),...
- Reason
- Kits contain a potentially contaminated component which were recalled by the manufacturer
Devices
Class II
Ongoing
Reported Sep 2, 2026
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) E...
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD...
- Firm
- Medline Industries, LP
- Codes
- Medline Kit SKU DYNJ0966146F, UDI/DI 10193489916379 (each) 40193489916370 (case), Lot Number 23HBC070; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case...
- Reason
- Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev...
Devices
Class II
Ongoing
Reported Sep 2, 2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Codes
- 191126, UDI/DI 00840861102099, Serial Numbers: 5T0S291116, 5T0S291119, 5T0S291125, 5T0S291135, 5T0S291137, 5T0S291138, 5T0S291139, 5T0S291140, 5T0S291141, 5T0S291143, 5T0S291144, 5...
- Reason
- Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis m...
Food
Class I
Ongoing
Reported Sep 2, 2026
Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
- Firm
- ZMB Enterprises
- Codes
- Sold between July - December 2025
- Reason
- The product contains 1,4-DMAA, Phenylethylamine and Phenibut.