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....
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Nationwide within the United States
- Firm
- Hikma Pharmaceuticals USA INC.
- Recall began
- Aug 24, 2026
- Quantity
- a) 25,970 bottles; b) 2,384 bottles
- Codes
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- FDA IDs
- D-0831-2026 / event 99711
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.
Foreign object: products may contain glass pieces
The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.
- Firm
- Dreyer's Grand Ice Cream Inc.
- Recall began
- Aug 18, 2026
- Quantity
- 644 pallets
- 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...
- FDA IDs
- H-1264-2026 / event 99716
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.
Foreign object: products may contain glass pieces
The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.
- Firm
- Dreyer's Grand Ice Cream Inc.
- Recall began
- Aug 18, 2026
- Quantity
- 685 pallets
- 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...
- FDA IDs
- H-1265-2026 / event 99716
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.
Foreign object: products may contain glass pieces
The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.
- Firm
- Dreyer's Grand Ice Cream Inc.
- Recall began
- Aug 18, 2026
- Quantity
- 281 pallets
- 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...
- FDA IDs
- H-1266-2026 / event 99716
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.
Foreign object: products may contain glass pieces
The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.
- Firm
- Dreyer's Grand Ice Cream Inc.
- Recall began
- Aug 18, 2026
- Quantity
- 226 pallets
- 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
- FDA IDs
- H-1268-2026 / event 99716
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
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Firm
- Olympus Corporation of the Americas
- Recall began
- Aug 18, 2026
- Quantity
- 335 units
- Codes
- Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
- FDA IDs
- Z-3035-2026 / event 99607
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.
Product had a presumptive positive test result for Listeria monocytogenes
The recalled product was distributed to the following States: IL, NV, NM, CA, OK, TX, PA, OH, NC, NY, GA, and AR.
- Firm
- CUISINE, KETTLE
- Recall began
- Aug 11, 2026
- Quantity
- 540 cases
- Codes
- Best By/ Use By: 8/22/2026
- FDA IDs
- H-1271-2026 / event 99690
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
Label does not declare walnuts in English
Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Foreign: Canada, Switzerland, Colombia, Germany, S...
- Firm
- Byron White Formulas, Inc.
- Recall began
- Aug 11, 2026
- Quantity
- 10,403 units
- Codes
- Lot Code Format = MMD,DYY: 022,224. 061,424. 092,324. 022,125. 071,825. 112,125. 040,826.
- FDA IDs
- H-1278-2026 / event 99629
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,...
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
US Nationwide.
- Firm
- Church & Dwight Co., Inc.
- Recall began
- Aug 10, 2026
- Quantity
- 318,600 cartons
- Codes
- Lot # UN52882, Exp Date: 04/30/2028; Lot # UN53431, Exp Date: 06/30/2028; Lot # UN60411, Exp Date: 08/31/2028.
- FDA IDs
- D-0790-2026 / event 99604
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...
Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list
8 wholesale and retail locations in IA, KY and IL
- Firm
- Africando Foods LLC
- Recall began
- Aug 10, 2026
- Quantity
- N/A
- 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
- FDA IDs
- N/A / event 99642
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...
Subpotent Drug
Nationwide within the United States
- Firm
- ACCORD HEALTHCARE, INC.
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- 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.
- FDA IDs
- D-0775-2026 / event 99584
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...
Subpotent Drug
Nationwide within the United States
- Firm
- ACCORD HEALTHCARE, INC.
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, Exp Date. 11/30/2026.
- FDA IDs
- D-0776-2026 / event 99584
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...
Subpotent Drug
Nationwide within the United States
- Firm
- ACCORD HEALTHCARE, INC.
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot #: D2402016, D2402017, Exp. Date 08/31/2026
- FDA IDs
- D-0777-2026 / event 99584
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...
Subpotent Drug
Nationwide within the United States
- Firm
- ACCORD HEALTHCARE, INC.
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot #: D2401983, Exp. Date 08/31/2026; D2402640, D2402641, Exp. Date 11/30/2026; D2500224, Exp. Date 01/31/2027.
- FDA IDs
- D-0781-2026 / event 99584
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...
Subpotent Drug
Nationwide within the United States
- Firm
- ACCORD HEALTHCARE, INC.
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- a) Lot # D2402125, D2402126, D2402127, Exp. Date 09/30/2026. b) Lot #: D2402523, D2402524, Exp. Date 11/30/2026.
- FDA IDs
- D-0782-2026 / event 99584
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...
Subpotent Drug
Nationwide within the United States
- Firm
- ACCORD HEALTHCARE, INC.
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot #: D2402195, D2402196, D2402197, Exp. Date 09/30/2026.
- FDA IDs
- D-0783-2026 / event 99584
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...
Subpotent Drug
Nationwide within the United States
- Firm
- ACCORD HEALTHCARE, INC.
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- a) Lot # D2402430, D2402431, Exp Date: 10/31/2026. b) Lot #: D2402432, Exp. Date 10/31/2026; D2500180, Exp. Date 12/31/2026.
- FDA IDs
- D-0785-2026 / event 99584
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...
Subpotent Drug
Nationwide within the United States
- Firm
- ACCORD HEALTHCARE, INC.
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot #: D2402337, Exp. Date 10/31/2026.
- FDA IDs
- D-0786-2026 / event 99584
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
Presence of particulate matter: glass and stopper piece
USA Nationwide
- Firm
- Mallinckrodt Hospital Products Inc.
- Recall began
- Aug 6, 2026
- Quantity
- 12367 vials
- Codes
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- FDA IDs
- D-0803-2026 / event 99570
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
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 may pose a risk of injury to the patient if unintended rota...
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Firm
- IMRIS Imaging Inc
- Recall began
- Aug 6, 2026
- Quantity
- 6 units
- Codes
- 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
- FDA IDs
- Z-3033-2026 / event 99596
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
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 may pose a risk of injury to the patient if unintended rota...
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Firm
- IMRIS Imaging Inc
- Recall began
- Aug 6, 2026
- Quantity
- 13 units
- Codes
- 114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462,...
- FDA IDs
- Z-3034-2026 / event 99596
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 #...
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 on finished product label.
Distribute in HI.
- Firm
- H & U Inc. dba Sun Noodle
- Recall began
- Aug 4, 2026
- Quantity
- 140 packages
- 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
- FDA IDs
- H-1258-2026 / event 99571
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...
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.
U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.
- Firm
- Canon Medical System, USA, INC.
- Recall began
- Aug 4, 2026
- Quantity
- 10 systems
- 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...
- FDA IDs
- Z-3014-2026 / event 99222
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...
Failed content uniformity specifications.
USA Nationwide
- Firm
- Lupin Pharmaceuticals Inc.
- Recall began
- Aug 3, 2026
- Quantity
- 5082 tubes
- Codes
- Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
- FDA IDs
- D-0789-2026 / event 99544
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...
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 (coconut).
Product was shipped to the following states: DC, DE, GA, MD, NJ, NY, NC, PA, SC, & VA.
- Firm
- Lidl US TRADING
- Recall began
- Jul 22, 2026
- Quantity
- 500 units
- Codes
- BEST BEFORE: 10/11/2026 LOT NO: 260315
- FDA IDs
- H-1274-2026 / event 99493
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...
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 (coconut).
Product was shipped to the following states: DC, DE, GA, MD, NJ, NY, NC, PA, SC, & VA.
- Firm
- Lidl US TRADING
- Recall began
- Jul 22, 2026
- Quantity
- 200 units
- Codes
- BEST BEFORE: 10/11/2026 LOT NO: 260315
- FDA IDs
- H-1275-2026 / event 99493
Devices
Class II
Ongoing
Reported Sep 2, 2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Software issue may cause measurements to be displayed inaccurately.
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Firm
- Merge Healthcare, Inc.
- Recall began
- Jul 22, 2026
- Quantity
- 20 units
- Codes
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
- FDA IDs
- Z-3004-2026 / event 99520
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
Undeclared peanuts.
Domestic: AZ, CA, CO, HI, NJ, OR, TX, WA. Foreign: Not applicable.
- Firm
- KHONG GUAN (HQ)
- Recall began
- Jul 13, 2026
- Quantity
- 87 cases (36 units/case)
- Codes
- USE BY: 10/19/2027; 9/22/2027
- FDA IDs
- H-1259-2026 / event 99424
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...
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. D...
Worldwide distribution - US Nationwide and the country of Panama.
- Firm
- Medline Industries, LP
- Recall began
- Jul 13, 2026
- Quantity
- 145525 units
- 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...
- FDA IDs
- Z-2992-2026 / event 99403
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...
Kits contain a potentially contaminated component which were recalled by the manufacturer
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Firm
- Medline Industries, LP
- Recall began
- Jul 10, 2026
- Quantity
- 94 kits
- Codes
- Medline Kit SKU CDS982040U, UDI/DI 10198459385421 (each) 40198459385422 (case), Lot Number 26AMC355; Medline Kit SKU DYNJ89608, UDI/DI 10198459279324 (each) 40198459279325 (case),...
- FDA IDs
- Z-3022-2026 / event 99507
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.
Kits contain a potentially contaminated component which were recalled by the manufacturer
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Firm
- Medline Industries, LP
- Recall began
- Jul 10, 2026
- Quantity
- 106 kits
- Codes
- Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26FMC710; Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case...
- FDA IDs
- Z-3026-2026 / event 99507
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...
Kits contain a potentially contaminated component which were recalled by the manufacturer
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Firm
- Medline Industries, LP
- Recall began
- Jul 10, 2026
- Quantity
- 419 kits
- Codes
- Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case)...
- FDA IDs
- Z-3028-2026 / event 99507
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...
Kits contain a potentially contaminated component which were recalled by the manufacturer
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Firm
- Medline Industries, LP
- Recall began
- Jul 10, 2026
- Quantity
- 241 kits
- Codes
- Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25LMF531; Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case),...
- FDA IDs
- Z-3029-2026 / event 99507
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...
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 levels of endotoxin of the neurosponges.
US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
- Firm
- Medline Industries, LP
- Recall began
- Jul 8, 2026
- Quantity
- 2262 kits
- Codes
- Medline Kit SKU DYNJ0966146F, UDI/DI 10193489916379 (each) 40193489916370 (case), Lot Number 23HBC070; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case...
- FDA IDs
- Z-2994-2026 / event 99489
Devices
Class II
Ongoing
Reported Sep 2, 2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
US Nationwide distribution.
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Recall began
- Jun 30, 2026
- Quantity
- 1140 systems
- Codes
- 191126, UDI/DI 00840861102099, Serial Numbers: 5T0S291116, 5T0S291119, 5T0S291125, 5T0S291135, 5T0S291137, 5T0S291138, 5T0S291139, 5T0S291140, 5T0S291141, 5T0S291143, 5T0S291144, 5...
- FDA IDs
- Z-3017-2026 / event 99438
Food
Class I
Ongoing
Reported Sep 2, 2026
Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
The product contains 1,4-DMAA, Phenylethylamine and Phenibut.
The firm markets their products online via their website addallxr.com
- Firm
- ZMB Enterprises
- Recall began
- Apr 3, 2026
- Quantity
- unknown
- Codes
- Sold between July - December 2025
- FDA IDs
- H-1263-2026 / event 98691