openFDA

Tracking U.S. FDA recalls

The most serious (Class I/II) FDA recalls of medical devices, drugs, and food, summarized with sources. Data from openFDA. This site is not an official U.S. government website.

This page is a general organization of U.S. public information and is not medical advice or diagnosis. Data is provided as-is and may contain errors. Base health and safety decisions on official information and professionals.

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High-severity recalls explained with key points, FAQs, and sources.

Class I (most serious) Medical Device Aug 19, 2026

Saline ampules recalled over a citation against the contract manufacturer - sterility is the most common reason of all (Spectra Medical Devices)

The U.S. FDA classified as Class I a recall of 0.9% Sodium Chloride Injection in 10 mL ampules sold by Spectra Medical Devices. The reason is that Huons, the manufacturing firm, was cited over product quality and sterility assurance.

Class I is the FDA's most serious recall category, applied where there is a reasonable probability of serious harm or death.
The product is 0.9% Sodium Chloride Injection in 10 mL ampules, used to flush IV tubing and indwelling intravascular access devices.
The firm cited was not the seller but Huons, the manufacturer, over product quality and sterility assurance.

Class I (most serious) Medical Device Aug 19, 2026

Bubbles appear only when the line is pressurised — a fault conditional on how it is used (Baxter, 24,528 units)

The U.S. Food and Drug Administration classified Baxter's Duo-Vent Solution Set (product code 1C8507), an IV administration set, as Class I — its most serious category. Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. The quantity is 24,528 units, distributed within the United States only.

Recall number Z-2766-2026; FDA Class I, the most serious category; status Ongoing.
The product is the Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, product code 1C8507 (a solution administration set).
The reason is customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or the tubing is flushed fully open.

Class I (most serious) Drug Aug 19, 2026

FDA Class I recall: herbal capsules found to contain undeclared steroid and antihistamine — 71 bottles sold through an eBay third-party seller

The U.S. Food and Drug Administration classified "Kian Pee Wan Capsules" (30-count bottles) sold by Buy-Herbal as Class I — its most serious category — because the product was marketed without an approved application and contains the undeclared drug ingredients dexamethasone and cyproheptadine. The quantity is 71 bottles, sold to individual consumers through an eBay third-party seller.

Recall number D-0769-2026; FDA Class I, the most serious category; status Ongoing.
The product is "Kian Pee Wan Capsules" in 30-count bottles; the recalling firm is located in New York.
The reason is marketing without an approved NDA/ANDA together with undeclared drug ingredients: dexamethasone and cyproheptadine.

Class I (most serious) Drug Aug 19, 2026

FDA Class I recall: an injectable out of specification for bacterial endotoxin — the pyrogen that survives killing the bacteria (Victory Medical Center Pharmacy)

The U.S. Food and Drug Administration classified a glutathione injectable (200 mg/mL, 30 mL vial) prepared by Victory Medical Center Pharmacy as Class I — its most serious category. The reason is microbial contamination of a sterile product: out-of-specification results were obtained for bacterial endotoxin. The quantity is 91 units, distributed nationwide.

Recall number D-0772-2026; FDA Class I, the most serious category; status Ongoing.
The product is a glutathione injectable (MDV), 200 mg/mL, 30 mL vial, recorded as containing ascorbic acid and benzyl alcohol 1.5% among other ingredients.
The reason is microbial contamination of a sterile product, with out-of-specification results for bacterial endotoxin.

Class I (most serious) Drug Aug 19, 2026

Plastic, steel and glass particles found in contrast-agent vials - why particulates matter in a drug that enters the bloodstream (Liebel-Flarsheim)

The U.S. FDA classified as Class I a recall of 3,486 500 mL vials of the X-ray contrast agent Optiray made by Liebel-Flarsheim. The reason is the presence of particulate matter comprising polyethylene and other plastics, stainless steel and glass.

The product is 3,486 500 mL multiple-dose vials of the X-ray contrast agent Optiray, classified Class I.
The reason is particulate matter comprising polyethylene and other plastics, stainless steel and glass.
Because a contrast agent enters the vasculature, particles travel with the blood rather than passing through the digestive tract.

Class I (most serious) Food Aug 19, 2026

Salmonella suspected in 1.59 million dozen eggs - one recall recorded across several rows (Midwest Poultry Services)

The U.S. FDA classified as Class I a recall of Grade A white in-shell chicken eggs shipped by Midwest Poultry Services. The reason is possible Salmonella Enteritidis, and the quantity totals 1,589,577 dozen.

The products are Kroger-brand Grade A white in-shell chicken eggs, totalling 1,589,577 dozen.
The reason is possible Salmonella Enteritidis, classified Class I.
Salmonella Enteritidis can enter the inside of an egg before it is laid, so washing the shell may not remove it.

Class I (most serious) Food Aug 19, 2026

The peanuts were not on the label - a recall where the problem is what was not written, not what got in (Bazzini)

The U.S. FDA classified as Class I a recall of 1,382,916 pieces of Dark Chocolate Coconut Almond Bites made by Bazzini. The reason is undeclared peanuts.

The product is Dark Chocolate Coconut Almond Bites in 3.17 oz pouches, totalling 1,382,916 pieces.
The reason is undeclared peanuts: the product is not contaminated, but an ingredient present in it is missing from the label.
Because the label is the only means of protection for someone with a food allergy, the most serious category applies even with nothing wrong in the product.

Class I (most serious) Food Aug 19, 2026

FDA Class I recall: brown shell eggs sold as Kroger's "Simple Truth" over possible Salmonella — 1,589,577 dozen on the record

The U.S. Food and Drug Administration classified Grade A brown in-shell chicken eggs shipped by Midwest Poultry Services as Class I — its most serious category — for possible Salmonella Enteritidis. The recall covers Kroger's "Simple Truth" cage-free packs (medium 12-count; large 12, 18, and 24-count) plus a bulk configuration. The record lists 1,589,577 dozen as the total, distributed to six states.

Recall number H-1229-2026; FDA Class I, the most serious category; status Ongoing.
The product is Grade A brown in-shell chicken eggs, including Kroger's own "Simple Truth" cage-free packs (medium 12-count; large 12, 18, 24-count) and a bulk line.
The reason is possible Salmonella Enteritidis.

Class I (most serious) Food Aug 12, 2026

FDA Class I recall: Listeria in cheese curd, quantity recorded as unknown, and the same product on other brands (Clover Hill Dairy)

The U.S. Food and Drug Administration classified Clover Hill Dairy's mild cheese variety (Fresh Cheddar Curd) as Class I — its most serious category — for contamination with Listeria monocytogenes. It was sold in roughly 0.75-lb and 1.5-lb boxes and distributed to Maryland, Virginia, and New York. The record states that packaging, labeling, and the total quantity distributed are unknown. The same firm's product was also recalled under other brands.

Recall number H-1208-2026; FDA Class I, the most serious category; status Ongoing.
The product is Clover Hill Dairy Fresh Cheddar Curd in roughly 0.75-lb and 1.5-lb boxes, kept refrigerated.
The reason is contamination with Listeria monocytogenes, a pathogen that grows at refrigerator temperature and is severe for pregnant women, newborns, older adults, and the immunocompromised.

Class I (most serious) Food Aug 12, 2026

One cheese plant, eighteen recall records - Listeria and a quantity recorded as unknown (Clover Hill Dairy)

The U.S. FDA classified as Class I a recall of Clover Hill Dairy flavored cheese (Old Bay Cheddar). The reason is contamination with Listeria monocytogenes, and this site holds 18 recall records tied to the firm.

The product is flavored cheese (Old Bay Cheddar), sold in units from half a pound to 40 pounds.
The reason is contamination with Listeria monocytogenes, classified Class I.
Listeria grows at refrigeration temperatures, making it a problem in refrigerated foods eaten without cooking.

Class I (most serious) Food Aug 12, 2026

A supplement containing the prescription drug tadalafil - the only such record among 1,408 (AKKARCO)

The U.S. FDA classified as Class I a recall of Ashfiat Alharamain Energy Support, 250 ml, sold by AKKARCO. The reason is undeclared tadalafil, an ingredient of prescription medicines.

The product is Ashfiat Alharamain Energy Support, 250 ml, totalling 1,052 units, classified Class I.
The reason is undeclared tadalafil, an ingredient of prescription medicines for erectile dysfunction.
Tadalafil can lower blood pressure to dangerous levels when combined with nitrates.

Class I (most serious) Food Aug 12, 2026

The repacker was recalled too - how a bulk shipment carries a recall downstream (La Colonia Foods)

The U.S. FDA classified as Class I a recall of 670 units of Salvadorean-style ricotta (requeson) from La Colonia Foods. The reason is possible contamination with Listeria monocytogenes, and the firm's related records include product bought in bulk from another company and repacked.

The product is Salvadorean-style ricotta (requeson), 14 oz, totalling 670 units, classified Class I.
The reason is possible contamination with Listeria monocytogenes; distribution reached Maryland and Virginia.
Related records for the firm include product bought in bulk from another company and packed into 18-pound buckets.

Class I (most serious) Medical Device Aug 12, 2026

A lead placed in the body can break where it was anchored — 13 device records concern an implant (Boston Scientific)

The U.S. Food and Drug Administration classified Boston Scientific's INFINION CX lead kits (50 cm and 70 cm) for its Spinal Cord Stimulator systems as Class I — its most serious category. The lead body may be exposed to stress at the anchor site, which can produce high impedance readings or lead fractures. That can leave stimulation inadequate and require further intervention, including explanting and replacing the lead. The quantity is 1,079 units.

Recall number Z-2879-2026; FDA Class I, the most serious category; status Ongoing.
The products are Boston Scientific INFINION CX lead kits, 50 cm (SC-2317-50) and 70 cm (SC-2317-70), for Spinal Cord Stimulator systems.
The reason is that the lead body may be exposed to stress at the anchor site, producing high impedance measurements or lead fractures.

Class I (most serious) Medical Device Aug 12, 2026

One component recall spreads into 18 records — particulate in a manifold pulled the surgical kits built around it into recall one after another

Convenience kits for cardiac catheterization sold by AVID Medical were recalled because of the recall of the Medline angiographic manifolds inside them. Particulate within the fluid path of the manifolds has the potential to enter blood circulation and lodge within blood vessels. Classification is Class I and 5,168 kits are covered.

AVID Medical cardiac catheterization convenience kits were recalled because of the recall of the Medline manifolds inside them.
Particulate within the fluid path of the manifolds has the potential to enter blood circulation and lodge within blood vessels.
5,168 kits are covered, classification is Class I, and recall initiation was 2026-04-30, with U.S. distribution to NC and TX.

Class I (most serious) Drug Aug 12, 2026

Stainless steel particulate in vials of the chemotherapy drug cyclophosphamide — when the manufacturer and the name on the label are different (Sunny Pharmtech)

The U.S. Food and Drug Administration classified cyclophosphamide for injection (2 g per vial) as Class I — its most serious category — for particulate matter identified as stainless steel. The recall is being conducted by Sunny Pharmtech, which manufactured it in Taiwan, while the label reads "Manufactured for Long Grove Pharmaceuticals." The quantity is 1,464 vials, distributed nationwide.

Recall number D-0744-2026; FDA Class I, the most serious category; status Ongoing.
The product is cyclophosphamide for injection, 2 g per vial, single-dose, prescription only, NDC 81298-8114-1; 1,464 vials distributed nationwide.
The reason is particulate matter identified as stainless steel; the record does not state a cause.

Class I (most serious) Medical Device Aug 5, 2026

168,069 ventilators fall under recall — electrolyte leaking from a board component can damage the charger chip and interrupt therapy

According to U.S. Food and Drug Administration recall records, 168,069 ResMed Astral 100/150 ventilators worldwide are covered by a recall because supercapacitor electrolyte leakage on the printed circuit board assembly may damage the charger chip, causing a fail-safe state and interruption of ventilation therapy. It carries the most serious classification, Class I.

168,069 ResMed Astral 100/150 ventilators worldwide are covered by the recall.
The reason is supercapacitor electrolyte leakage on the printed circuit board assembly, which may damage the charger chip, cause a fail-safe state and interrupt ventilation therapy.
Classification is Class I, the most serious level. Recall initiation was 2026-06-25.

Class I (most serious) Medical Device Jul 29, 2026

The kit inside the surgical kit was the subject — 11 device records name an included component (Medline)

The U.S. FDA classified 52 units of the Medline Industries surgical convenience kit "HIP CDS-LF" as Class I — its most serious category — because the kit contains an ICU Medical pain management kit (with Bupivacaine Hydrochloride in Dextrose Injection) that had been recalled for quality issues that could result in drug ineffectiveness.

Recall number Z-2764-2026; FDA Class I, the most serious category; status Ongoing.
The product is the Medline surgical convenience kit "HIP CDS-LF" (SKU CDS984556N).
The reason is that an ICU Medical pain management kit inside it (with Bupivacaine Hydrochloride in Dextrose Injection) had been recalled for quality issues that could result in drug ineffectiveness.

Class I (most serious) Food Jul 29, 2026

The same reason text stands in another record too — 178 of 534 wordings are shared (Green Jeeva)

The U.S. FDA classified 2,490 kg of bulk "Organic Moringa Powder" (15 kg bags, product code GJ96) from Green Jeeva LLC as Class I — its most serious category — after the moringa powder ingredient tested positive for Salmonella. The material went to four consignees who used it for further processing and distribution.

Recall number H-1180-2026; FDA Class I, the most serious category; status Ongoing.
The product is bulk "Organic Moringa Powder," 15 kg bags, product code GJ96, totaling 2,490 kg.
The reason is that the moringa powder ingredient tested positive for Salmonella.

Class I (most serious) Food Jul 29, 2026

Three unapproved substances in a supplement sold for three and a half years — 22 records of the kind (Modern Warrior Life)

The U.S. FDA classified "Modern Warrior Ready" (60 capsules) from Modern Warrior Life, LLC as Class I — its most serious category — after FDA analysis revealed unapproved ingredients including tianeptine, 1,4-DMAA, and aniracetam. The product had been distributed nationwide from April 2022 until December 8, 2025.

Recall number H-1178-2026; FDA Class I, the most serious category; status Ongoing.
The product is "Modern Warrior Ready, Dietary Supplement, 60 CAPSULES."
The reason is FDA analysis revealing unapproved ingredients: tianeptine, 1,4-DMAA, and aniracetam.

Class I (most serious) Food Jul 29, 2026

The first letter of the number tells you the product type — Z is 779 devices, H is 340 foods (Total Nutrition)

The U.S. FDA classified "TNVitamins 100% Organic Moringa Capsules 1,200 mg" and "TNVitamins 100% Organic Moringa Powder 96 grams" from Total Nutrition Inc as Class I — its most serious category — for Salmonella contamination. The quantity totals 8,492 units, distributed nationwide.

Recall number H-1185-2026; FDA Class I, the most serious category; status Ongoing.
Two items: "TNVitamins 100% Organic Moringa Capsules 1,200 mg" and "TNVitamins 100% Organic Moringa Powder 96 grams."
The reason is contamination with Salmonella.

Class I (most serious) Food Jul 29, 2026

Six states is about average in the records — the median is five (Gellert Global Group)

The U.S. Food and Drug Administration classified "Fusia Asian Inspirations Kimchi & Tofu Kimbap" (8.1 oz / 230 g), handled by Gellert Global Group, as Class I — its most serious category — for an undeclared fish allergen. The quantity is 29,850 units, distributed across six states.

Recall number H-1186-2026; FDA Class I, the most serious category; status Ongoing.
The product is "Fusia, Asian Inspirations, Kimchi & Tofu Kimbap," 8.1 oz (230 g), in a paper film wrapper.
The reason is an undeclared fish allergen.

Class I (most serious) Medical Device Jul 22, 2026

A leak risk in the part packed with every pump — eight in ten device records are Class II, and this is the other two (Abiomed)

The U.S. FDA classified Abiomed's Impella CP pump sets as a Class I recall, its most serious category, citing a potential for leakage from the introducer sheath that is supplied with the pump. The recall covers 87,277 units distributed worldwide.

The FDA classified it Class I, its most serious category (Z-2682-2026, reported July 22, 2026, status ongoing).
The recall covers the ABIOMED Impella CP Set (pump set code 0048-0003) with its 14 Fr introducer (product code 0052-3046) — 87,277 units.
The defect is potential leakage from under the sheath cap and along the hub score lines in 14 Fr and 23 Fr introducers.

Class I (most serious) Medical Device Jul 22, 2026

A component maker's recall reached 32,934 finished units — 107 records name a supplier (Oscor)

The U.S. FDA classified 32,934 introducer kits made by Oscor Inc. for the Impella heart pump as Class I — its most serious category — because manufacturing issues may allow the sheath to leak. The record lists distribution to a single state, Massachusetts.

Recall number Z-2680-2026; FDA Class I, the most serious category; status Ongoing.
The product is the "Hemostatic Peel Away Introducer System with Infusion Sideport, 23F" for Impella (Abiomed REF: 0052-3006).
The reason is potential leakage from manufacturing issues — at the sidearm, under the sheath cap, and along the hub score lines (14Fr and 23Fr).

Class I (most serious) Medical Device Jul 22, 2026

A leak the user cannot see — 15 device records turn on what is visible (Abiomed)

The U.S. FDA classified the "ABIOMED Introducer Kit 23 Fr, 11 cm" (pump set code 1000441) from Abiomed, Inc. as Class I — its most serious category — for potential sheath leakage. The record states plainly that the manufacturing issues are not visually detectable by the user, and distribution spans many countries including Japan.

Recall number Z-2684-2026; FDA Class I, the most serious category; status Ongoing.
The product is the "ABIOMED Introducer Kit 23 Fr, 11 cm" (pump set code 1000441; introducer product code 2000342).
The FDA record states the manufacturing issues are not visually detectable by the user — inspection at the point of use cannot catch them.

Class I (most serious) Food Jul 22, 2026

Freezing does not kill the organism — only three records name E. coli (Chilean blueberries)

The U.S. FDA classified organic frozen whole blueberries shipped by Chile-based Frutas y Hortalizas del Sur S.A. as a Class I recall, its most serious category, citing potential contamination with E. coli O145:H28. The recall covers 3,640 cases distributed in Florida.

The FDA classified it Class I, its most serious category (H-1181-2026, reported July 22, 2026, status ongoing).
The recall covers organic frozen whole blueberries in 10 oz bags (8 bags per case), 3,640 cases; lot 6040 01, best by February 9, 2028.
The stated reason is potential E. coli O145:H28 contamination; O145 is a leading non-O157 Shiga toxin-producing (STEC) serotype.

Class I (most serious) Food Jul 22, 2026

Five undeclared items listed at once — 32 records name more than one allergen (D'Dioses Fruit Pops)

The U.S. FDA classified "Ice Pop, D'Dioses Guayaba" (1 bar, 81.7 g) from D'Dioses Fruit Pops as Class I — its most serious category — because it may contain undeclared milk, pecans, pistachios, Yellow #5, and Red #40. Forty cases were distributed across four states.

Recall number H-1162-2026; FDA Class I, the most serious category; status Ongoing.
The product is "Ice Pop, D'Dioses Guayaba," 1 bar of 81.7 g, UPC 827912008432.
The reason is that it may contain undeclared milk, pecans, pistachios, Yellow #5, and Red #40.

Class I (most serious) Food Jul 15, 2026

Undeclared sesame in a foodservice spice blend — the newest addition to the U.S. list of major allergens (Adams Extract & Spice)

The U.S. Food and Drug Administration classified Adams Extract & Spice's foodservice "Smoked Sausage Spice" as Class I — its most serious category — for an undeclared sesame allergen. The quantity is 120 units, distributed within Texas. Sesame is the most recent food added to the U.S. list of major allergens.

Recall number H-1138-2026; FDA Class I, the most serious category; status Ongoing.
The product is the foodservice "Smoked Sausage Spice 32.86#"; the reason is an undeclared sesame allergen.
Sesame became the ninth major U.S. food allergen under the FASTER Act of 2021, with labeling required from January 1, 2023.

Class I (most serious) Food Jul 15, 2026

FDA Class I recall: undeclared peanut in chocolate covered raisins caused by mis-packaging (Lehi Valley Trading)

The U.S. FDA classified High Valley Orchard Chocolate Covered Raisins, distributed by Lehi Valley Trading Company, as a Class I recall, its most serious category, because mis-packaging left undeclared peanut in the product. The recall covers 624 containers (585 pounds) distributed in Arizona, Nevada, New Mexico and Texas.

The FDA classified it Class I, its most serious category (H-1150-2026, reported July 15, 2026, status ongoing).
The recall covers 624 High Valley Orchard Chocolate Covered Raisins 15 oz containers (585 lb total), lot 0160933, best by January 23, 2027.
The stated reason is undeclared peanut resulting from mis-packaging; the label declares milk and soy.

Class I (most serious) Medical Device Jul 8, 2026

Insulin pump cannula damage (Z-2603-2026) — how to read a quantity of 4.9 million

A recall began for disposable pumps worn on the body after manufacturing damage to a thin cannula allowed insulin to leak around the pod instead of reaching the user. The quantity is 4,936,056. What that figure means depends on what counts as one unit.

Manufacturing damage to the soft outer cannula allows insulin to leak around the pod rather than reach the user.
The primary failure mode is under-delivery, and the stated reason names severe conditions and death among what can follow.
The quantity is 4,936,056 units, the class is I, and distribution covers the United States plus twenty countries.

Class I (most serious) Medical Device Jul 8, 2026

An expiratory valve membrane that may stick, leaving breath unable to escape — 56 device records mention injury, four mention death (27,270 breathing circuits)

In coaxial breathing circuit sets used with HAMILTON-C1, T1 and MR1 ventilators, membranes in the expiratory valve set may stick to the valve body. The record states the fault is not detectable during the pre-operative test. Classified Class I for possible inadequate ventilation and oxygen desaturation; 27,270 pieces reached 43 states and Puerto Rico.

The product is the coaxial breathing circuit set (REF 260127, 260128, 260167, 260168) for HAMILTON-C1, T1 and MR1 ventilators — 27,270 pieces.
Membranes in the expiratory valve set may stick to the valve body, producing an exhalation obstructed alarm and possible inadequate ventilation and oxygen desaturation.
The record states plainly that the fault is not detectable during the pre-operative test.

Latest (original, serious recalls)

Recent recalls

Recently reported serious (Class I/II) recalls (original). Each is based on official primary information.

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Class II Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg... Drug ・ Baxter Healthcare Corporation ・ Sep 9, 2026
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Class II Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single... Drug ・ Baxter Healthcare Corporation ・ Sep 9, 2026
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Class II THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocryle... Drug ・ Allies Group Inc. ・ Sep 9, 2026
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Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.

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