Recall Code Clues

A no-JavaScript view of lot, batch, model, serial, expiration, and other code fields in the latest loaded openFDA recall snapshot. Use this when the label or notice has a code in front of you. Codes can be long, partial, or formatted differently across FDA records, so confirm the product, firm, reason text, and source record before acting. For private comparison, use the match checker; for broader browsing, use the latest digest, product clues, firm index, reason clues, or location clues.

GeneratedSep 7, 2026, 6:36 PM EDT
Code Records36
Class I3
Categories3
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).

a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027

Firm
Hikma Pharmaceuticals USA INC.
Quantity
a) 25,970 bottles; b) 2,384 bottles
FDA IDs
D-0831-2026 / event 99711
Source
openFDA source record
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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

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 LLA617503 30 SEP 2027 LLA617603 30 SEP 2027 LLA620303 31 OCT 2027 LLA620403 31 OCT 2027 LLA620503 31 OCT 2027 LLA620603 31 OCT 2027 LLA620703 31 OCT 2027 LLA620803 31 OCT 2027 LLA620903 31 OCT 2027 LLA621003 31 OCT 2027 LLA621103 31 OCT 2027 LLA621203 31 OCT 2027 LLA621303 30 NOV 2027 LLA621403 30 NOV 2027 LLA621503 30 NOV 2027 LLA621603 30...

Firm
Dreyer's Grand Ice Cream Inc.
Quantity
644 pallets
FDA IDs
H-1264-2026 / event 99716
Source
openFDA source record
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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

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 LLA618203 31 JUL 2027 LLA618303 31 JUL 2027 LLA618403 31 JUL 2027 LLA618503 31 JUL 2027 LLA619003 31 JUL 2027 LLA619103 31 JUL 2027 LLA619203 31 JUL 2027 LLA619303 31 JUL 2027 LLA619403 31 JUL 2027 LLA619503 31 JUL 2027

Firm
Dreyer's Grand Ice Cream Inc.
Quantity
685 pallets
FDA IDs
H-1265-2026 / event 99716
Source
openFDA source record
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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

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 31 OCT 2027 LLA620003 31 OCT 2027 LLA620103 31 OCT 2027 LLA620203 31 OCT 2027 LLA620303 31 OCT 2027

Firm
Dreyer's Grand Ice Cream Inc.
Quantity
281 pallets
FDA IDs
H-1266-2026 / event 99716
Source
openFDA source record
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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

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

Firm
Dreyer's Grand Ice Cream Inc.
Quantity
226 pallets
FDA IDs
H-1268-2026 / event 99716
Source
openFDA source record
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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.

Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.

Firm
Olympus Corporation of the Americas
Quantity
335 units
FDA IDs
Z-3035-2026 / event 99607
Source
openFDA source record
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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

Best By/ Use By: 8/22/2026

Firm
CUISINE, KETTLE
Quantity
540 cases
FDA IDs
H-1271-2026 / event 99690
Source
openFDA source record
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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

Lot Code Format = MMD,DYY: 022,224. 061,424. 092,324. 022,125. 071,825. 112,125. 040,826.

Firm
Byron White Formulas, Inc.
Quantity
10,403 units
FDA IDs
H-1278-2026 / event 99629
Source
openFDA source record
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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

Lot # UN52882, Exp Date: 04/30/2028; Lot # UN53431, Exp Date: 06/30/2028; Lot # UN60411, Exp Date: 08/31/2028.

Firm
Church & Dwight Co., Inc.
Quantity
318,600 cartons
FDA IDs
D-0790-2026 / event 99604
Source
openFDA source record
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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

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

Firm
Africando Foods LLC
Quantity
N/A
FDA IDs
N/A / event 99642
Source
openFDA source record
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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

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.

Firm
ACCORD HEALTHCARE, INC.
Quantity
N/A
FDA IDs
D-0775-2026 / event 99584
Source
openFDA source record
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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

Lot #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, Exp Date. 11/30/2026.

Firm
ACCORD HEALTHCARE, INC.
Quantity
N/A
FDA IDs
D-0776-2026 / event 99584
Source
openFDA source record
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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

Lot #: D2402016, D2402017, Exp. Date 08/31/2026

Firm
ACCORD HEALTHCARE, INC.
Quantity
N/A
FDA IDs
D-0777-2026 / event 99584
Source
openFDA source record
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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

Lot #: D2401983, Exp. Date 08/31/2026; D2402640, D2402641, Exp. Date 11/30/2026; D2500224, Exp. Date 01/31/2027.

Firm
ACCORD HEALTHCARE, INC.
Quantity
N/A
FDA IDs
D-0781-2026 / event 99584
Source
openFDA source record
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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

a) Lot # D2402125, D2402126, D2402127, Exp. Date 09/30/2026. b) Lot #: D2402523, D2402524, Exp. Date 11/30/2026.

Firm
ACCORD HEALTHCARE, INC.
Quantity
N/A
FDA IDs
D-0782-2026 / event 99584
Source
openFDA source record
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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

Lot #: D2402195, D2402196, D2402197, Exp. Date 09/30/2026.

Firm
ACCORD HEALTHCARE, INC.
Quantity
N/A
FDA IDs
D-0783-2026 / event 99584
Source
openFDA source record
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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

a) Lot # D2402430, D2402431, Exp Date: 10/31/2026. b) Lot #: D2402432, Exp. Date 10/31/2026; D2500180, Exp. Date 12/31/2026.

Firm
ACCORD HEALTHCARE, INC.
Quantity
N/A
FDA IDs
D-0785-2026 / event 99584
Source
openFDA source record
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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

Lot #: D2402337, Exp. Date 10/31/2026.

Firm
ACCORD HEALTHCARE, INC.
Quantity
N/A
FDA IDs
D-0786-2026 / event 99584
Source
openFDA source record
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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

Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027

Firm
Mallinckrodt Hospital Products Inc.
Quantity
12367 vials
FDA IDs
D-0803-2026 / event 99570
Source
openFDA source record
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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 patien...

113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997

Firm
IMRIS Imaging Inc
Quantity
6 units
FDA IDs
Z-3033-2026 / event 99596
Source
openFDA source record
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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 patien...

114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376

Firm
IMRIS Imaging Inc
Quantity
13 units
FDA IDs
Z-3034-2026 / event 99596
Source
openFDA source record
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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.

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

Firm
H & U Inc. dba Sun Noodle
Quantity
140 packages
FDA IDs
H-1258-2026 / event 99571
Source
openFDA source record
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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.

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: SGC2412001 Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30029686 Serial Number: SZA2422001 SID Number: 79000002 Serial Number:SZA2442004 Model Number: INFX-8000V/SX UDI code: Pending SID Number: 30049491 Serial Number: SXA2432001 SID Number: 30100053 Serial Number: SXA2432002 Model Number: INFX-8000V/B9 UDI code: Pending SID Number...

Firm
Canon Medical System, USA, INC.
Quantity
10 systems
FDA IDs
Z-3014-2026 / event 99222
Source
openFDA source record
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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.

Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026

Firm
Lupin Pharmaceuticals Inc.
Quantity
5082 tubes
FDA IDs
D-0789-2026 / event 99544
Source
openFDA source record
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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).

BEST BEFORE: 10/11/2026 LOT NO: 260315

Firm
Lidl US TRADING
Quantity
500 units
FDA IDs
H-1274-2026 / event 99493
Source
openFDA source record
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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).

BEST BEFORE: 10/11/2026 LOT NO: 260315

Firm
Lidl US TRADING
Quantity
200 units
FDA IDs
H-1275-2026 / event 99493
Source
openFDA source record
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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.

Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409

Firm
Merge Healthcare, Inc.
Quantity
20 units
FDA IDs
Z-3004-2026 / event 99520
Source
openFDA source record
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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 localiz...

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) Discontinued (case), All lot numbers; 3) Medline Product Number/SKU 780-13, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 4) Medline Product Number/SKU 780-14, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 5) Medline Product Number/SKU 780-15, UDI/DI Discontinued (each) Discontinued (case), All lot number...

Firm
Medline Industries, LP
Quantity
145525 units
FDA IDs
Z-2992-2026 / event 99403
Source
openFDA source record
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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

Medline Kit SKU CDS982040U, UDI/DI 10198459385421 (each) 40198459385422 (case), Lot Number 26AMC355; Medline Kit SKU DYNJ89608, UDI/DI 10198459279324 (each) 40198459279325 (case), Lot Number 25JBR465; Medline Kit SKU DYNJ903479L, UDI/DI 10198459255250 (each) 40198459255251 (case), Lot Number 25LMB480; Medline Kit SKU DYNJ903479M, UDI/DI 10198459790591 (each) 40198459790592 (case), Lot Number 26FMB173.

Firm
Medline Industries, LP
Quantity
94 kits
FDA IDs
Z-3022-2026 / event 99507
Source
openFDA source record
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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

Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26FMC710; Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26DMG417; Medline Kit SKU DYNJ911755, UDI/DI 10198459523946 (each) 40198459523947 (case), Lot Number 25KMI628; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABJ549; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABI899; Medline Kit S...

Firm
Medline Industries, LP
Quantity
106 kits
FDA IDs
Z-3026-2026 / event 99507
Source
openFDA source record
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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

Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case), Lot Number 25IBP434; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 26BBA665; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25KBR602; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25JBH531; Medline Kit...

Firm
Medline Industries, LP
Quantity
419 kits
FDA IDs
Z-3028-2026 / event 99507
Source
openFDA source record
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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

Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25LMF531; Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25JML577; Medline Kit SKU DYNJT6104, UDI/DI 10198459539374 (each) 40198459539375 (case), Lot Number 25JBM473; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDB085; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDA481; Medline Kit SK...

Firm
Medline Industries, LP
Quantity
241 kits
FDA IDs
Z-3029-2026 / event 99507
Source
openFDA source record
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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.

Medline Kit SKU DYNJ0966146F, UDI/DI 10193489916379 (each) 40193489916370 (case), Lot Number 23HBC070; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 24CBA416; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23CBS214; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23FBC803; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23GBU042; Medline Kit S...

Firm
Medline Industries, LP
Quantity
2262 kits
FDA IDs
Z-2994-2026 / event 99489
Source
openFDA source record
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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.

191126, UDI/DI 00840861102099, Serial Numbers: 5T0S291116, 5T0S291119, 5T0S291125, 5T0S291135, 5T0S291137, 5T0S291138, 5T0S291139, 5T0S291140, 5T0S291141, 5T0S291143, 5T0S291144, 5T0S291145, 5T0S291146, 5T0S291148, 5T0S291149, 5T0S291150, 5T0S291151, 5T0S291152, 5T0S291154, 5T0S291155, 5T0S291156, 5T0S291157, 5T0S291158, 5T0S291159, 5T0S291160, 5T0S291161, 5T0S291162, 5T0S291163, 5T0S291164, 5T0S291165, 5T0S291166, 5T0S291168, 5T0S291169, 5T0S291170, 5T0S291173, 5T0S291177, 5T0S291178, 5T0S291179, 5T0S291180, 5T0S2...

Firm
Fresenius Medical Care Renal Therapies Group, LLC
Quantity
1140 systems
FDA IDs
Z-3017-2026 / event 99438
Source
openFDA source record
Search this code in Recall Radar Check this code privately