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Recalls affecting Louisiana

Data last updated: September 8, 2026 at 1:13 PM UTC

16,895 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
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High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98907
Lot/product code:
UDI-DI 10350770007752, Lot Number 30370713
Recalling firm:
Avanos Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98907
Lot/product code:
UDI-DI 10350770007806, Lot Numbers 30371316, 30377829, 80403341
Recalling firm:
Avanos Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98944
Lot/product code:
REF/UDI/Lot: 04.01.10.0970/07630542768910/2585086, 04.01.10.0971/07630542768927/2585087, 04.01.10.0972/07630542768934/2585088, 04.01.10.0973/07630542768941/2585089, 04.01.10.0974/07630542768958/2585090, 04.01.10.0975/07630542768965/2585091, 04.01.10.0976/07630542768972/2585092, 04.01.10.0977/07630542768989/2585093, 04.01.10.0978/07630542768996/2585094, 04.01.10.0979/07630542769009/2585095
Recalling firm:
Medacta Usa Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

BD Pyxis MedStation ES REF: 323 Medication cabinet

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98895
Lot/product code:
All Serial Numbers/UDI:10885403512667
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98918
Lot/product code:
UDI: 06429811532137 ; All lots until the IFU update has been implemented
Recalling firm:
SURGIFY MEDICAL OY
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98907
Lot/product code:
Lot Code: Model No 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342
Recalling firm:
Avanos Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-5320

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98907
Lot/product code:
UDI-DI 10350770007516, Lot Numbers 30365231, 30371022, 30373824, 30378385, 30383807, 30385321
Recalling firm:
Avanos Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98907
Lot/product code:
Lot Code: Model No 7170-20, UDI-DI 10350770007776, Lot Numbers 30370714, 30373419, 30374048, 30378746
Recalling firm:
Avanos Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98907
Lot/product code:
Lot Code: Model No 30-6316, UDI-DI 10350770007561, Lot Numbers 30365229 and 30376100
Recalling firm:
Avanos Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98826
Lot/product code:
1. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 445, 1555, 1114, 1529, 472, 1349, 1594, 1311, 1472, 1187, 1700, 1031, 912, 913, 940, 285, 1637, 5, 797, 639, 452, 1585, 535, 1338, 1641, 1916, 614, 605, 492, 1612, 505, 239, 1216, 1169, 1118, 115, 519, 356, 715, 423, 1399, 789, 1509, 1016, 875, 1923, 313, 314, 1919, 1458, 369, 1176, 1230, 1925, 339, 1325, 1633, 596, 1784, 464, 796, 1928, 1025, 292, 1669, 1697, 708, 1, 1760, 1452, 346, 961, 1172, 354, 416, 363, 582, 161, 569, 922; 2. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)1123, (01)00884838059030(21)932, (01)00884838059030(21)239, (01)00884838059030(21)360, (01)00884838059030(21)500, (01)00884838059030(21)794, (01)00884838059030(21)939, (01)00884838059030(21)921, (01)00884838059030(21)286, (01)00884838059030(21)1440, (01)00884838059030(21)1144, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)107, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)656, (01)00884838059030(21)1261, (01)00884838059030(21)1170, (01)00884838059030(21)585, (01)00884838059030(21)1128, (01)00884838059030(21)882, (01)00884838059030(21)1230, (01)00884838059030(21)280, (01)00884838059030(21)488, (01)00884838059030(21)787, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)190, (01)00884838059030(21)1181, (01)00884838059030(21)694, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)1149, (01)00884838059030(21)423, (01)00884838059030(21)1176, (01)00884838059030(21)1173, (01)00884838059030(21)1040, (01)00884838059030(21)1309, (01)00884838059030(21)763, (01)00884838059030(21)931, (01)00884838059030(21)478, (01)00884838059030(21)1298, (01)00884838059030(21)970, (01)00884838059030(21)1226, (01)00884838059030(21)290, (01)00884838059030(21)365, (01)00884838059030(21)651, (01)00884838059030(21)1292, (01)00884838059030(21)1275, (01)00884838059030(21)755, (01)00884838059030(21)671, (01)00884838059030(21)677, (01)00884838059030(21)1336, (01)00884838059030(21)477, (01)00884838059030(21)1078, (01)00884838059030(21)467, (01)00884838059030(21)1369, (01)00884838059030(21)792, (01)00884838059030(21)679, (01)00884838059030(21)485, (01)00884838059030(21)395, (01)00884838059030(21)592, (01)00884838059030(21)1312, (01)00884838059030(21)1302, (01)00884838059030(21)505, (01)00884838059030(21)714, (01)00884838059030(21)414, (01)00884838059030(21)785, (01)00884838059030(21)1283, (01)00884838059030(21)119, (01)00884838059030(21)662, (01)00884838059030(21)698, (01)00884838059030(21)690, (01)00884838059030(21)1235, (01)00884838059030(21)1233, (01)00884838059030(21)1236, (01)00884838059030(21)1234, (01)00884838059030(21)158, (01)00884838059030(21)1009, (01)00884838059030(21)992, (01)00884838059030(21)1214, (01)00884838059030(21)1064, (01)00884838059030(21)979, (01)00884838059030(21)764, (01)00884838059030(21)920, (01)00884838059030(21)788, (01)00884838059030(21)1396, (01)00884838059030(21)902, (01)00884838059030(21)1344, (01)00884838059030(21)1183, (01)00884838059030(21)453, (01)00884838059030(21)1118, (01)00884838059030(21)411, (01)00884838059030(21)1210, (01)00884838059030(21)1209, (01)00884838059030(21)1041, (01)00884838059030(21)1042, (01)00884838059030(21)1432, (01)00884838059030(21)308, (01)00884838059030(21)833, (01)00884838059030(21)1310, (01)00884838059030(21)728, (01)00884838059030(21)791, (01)00884838059030(21)480, (01)00884838059030(21)1263, (01)00884838059030(21)987, (01)00884838059030(21)986, (01)00884838059030(21)422, (01)00884838059030(21)905, (01)00884838059030(21)218, (01)00884838059030(21)1005, (01)00884838059030(21)1425, (01)00884838059030(21)1397, (01)00884838059030(21)1398, (01)00884838059030(21)1132, (01)00884838059030(21)468, (01)00884838059030(21)1442, (01)00884838059030(21)1048, (01)00884838059030(21)648, (01)00884838059030(21)646, (01)00884838059030(21)1126, (01)00884838059030(21)873, (01)00884838059030(21)252, (01)00884838059030(21)343, (01)00884838059030(21)1011, (01)00884838059030(21)1370, (01)00884838059030(21)838, (01)00884838059030(21)1391, (01)00884838059030(21)999, (01)00884838059030(21)285, (01)00884838059030(21)636, (01)00884838059030(21)624, (01)00884838059030(21)241, (01)00884838059030(21)1084, (01)00884838059030(21)896, (01)00884838059030(21)673, (01)00884838059030(21)683, (01)00884838059030(21)1441, (01)00884838059030(21)914, (01)00884838059030(21)531, (01)00884838059030(21)818, (01)00884838059030(21)1395, (01)00884838059030(21)637, (01)00884838059030(21)917, (01)00884838059030(21)214, (01)00884838059030(21)1043, (01)00884838059030(21)1365, (01)00884838059030(21)1109, (01)00884838059030(21)1297, (01)00884838059030(21)572, (01)00884838059030(21)1436, (01)00884838059030(21)638, (01)00884838059030(21)1112, (01)00884838059030(21)1373, (01)00884838059030(21)946, (01)00884838059030(21)878, (01)00884838059030(21)1108, (01)00884838059030(21)809, (01)00884838059030(21)830, (01)00884838059030(21)839, (01)00884838059030(21)… (truncated, 205424 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98907
Lot/product code:
UDI-DI 10350770007585, Lot Numbers 30365226 and 30382750
Recalling firm:
Avanos Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm) REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm); REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm)

Reusable electrodes may not meet expected performance levels.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98939
Lot/product code:
All Lots: / UDI: CSK-TC10:00813250010107; CSK-TC10-3M: 00813250011524; CSK-TC15 00813250010114; CSK-TC15-3M: 00813250011548 CSK-TC20: 0081325001140; CSK-TC5: 00813250010091; CSK-TC5-3M: 00813250011531;
Recalling firm:
Boston Scientific Neuromodulation Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0545-2026
Lot/product code:
Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Plum Duo Precision IV Pump, 40002-0403

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

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FDA has not published a risk classification for this recall yet.

Recall #:
98872
Lot/product code:
UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Sterile anchors my lack sterility assurance.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98941
Lot/product code:
GTIN: 08714729905318/Lot # 35107836
Recalling firm:
Boston Scientific Neuromodulation Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98891
Lot/product code:
1. Product Number (CFN): 8888221413; UDI-DI: 10884521788541; Lot numbers: 241620022, 252020038; 2. Product Number (CFN): 8888222416; UDI-DI: 10884521788602; Lot numbers: 241690023, 241830147; 3. Product Number (CFN): 8888221416; UDI-DI: 10884521788558; Lot numbers: 251250041, 251740190, 252020039, 252090031, 253350256; 4. Product Number (CFN): 8888222420; UDI-DI: 10884521788619; Lot numbers: 251740186, 252510026, 253280016; 5. Product Number (CFN): 8888221420; UDI-DI: 10884521788565; Lot numbers: 241620407, 251950032; 6. Product Number (CFN): 8888222424; UDI-DI: 10884521788626; Lot number: 243040007; 7. Product Number (CFN): 8888221424; UDI-DI: 10884521788572; Lot numbers: 241200034, 251250039, 252020037; 8. Product Number (CFN): 8888221430; UDI-DI: 10884521788589; Lot number: 251250042; 9. Product Number (CFN): 8888233413; UDI-DI: 10884521788718; Lot number: 250310009; 10. Product Number (CFN): 8888233416; UDI-DI: 10884521788725; Lot numbers: 250350008, 250690152, 250690153, 250870012, 251010012, 251010013, 251320332, 251320333, 251390368, 251390369, 252580023; 11. Product Number (CFN): 8888233420; UDI-DI: 10884521788732; Lot numbers: 250870013, 250970052, 251320330, 251320331; 12. Product Number (CFN): 8888231420; UDI-DI: 10884521788688; Lot numbers: 241690216, 252020046, 252230023, 252580025; 13. Product Number (CFN): 8888233424; UDI-DI: 10884521788749; Lot numbers: 251740197, 252300054; 14. Product Number (CFN): 8888231424; UDI-DI: 10884521788695; Lot numbers: 251460351, 251740196, 252020045, 252230022, 252580024; 15. Product Number (CFN): 8888231430; UDI-DI: 10884521788701; Lot number: 252730009; 16. Product Number (CFN): 8888231413; UDI-DI: 10884521788664; Lot number: 250310010; 17. Product Number (CFN): 8888231416; UDI-DI: 10884521788671; Lot numbers: 252230021, 252510030, 252650294, 253140280; 18. Product Number (CFN): 8888213416; UDI-DI: 10884521788527; Lot number: 252300325; 19. Product Number (CFN): 8888211416; UDI-DI: 10884521788435; Lot numbers: 241060237, 250830187, 250900067, 251250037, 251430012, 252870014; 20. Product Number (CFN): 8888213420; UDI-DI: 10884521788534; Lot number: 252300051; 21. Product Number (CFN): 8888211420; UDI-DI: 10884521788442; Lot numbers: 241480021, 242390056, 250070005, 250310011, 250310012, 250760180, 250900066, 251250035, 251950034; 22. Product Number (CFN): 8888212413; UDI-DI: 10884521788473; Lot number: 242950260; 23. Product Number (CFN): 8888211413; UDI-DI: 10884521788428; Lot number: 252510028; 24. Product Number (CFN): 8888212416; UDI-DI: 10884521788480; Lot numbers: 243160028, 250760159, 251250036, 251320325; 25. Product Number (CFN): 8888212420; UDI-DI: 10884521788497; Lot numbers: 241350005, 250310006, 251740192, 252160037; 26. Product Number (CFN): 8888211424; UDI-DI: 10884521788459; Lot numbers: 250830185, 250830186, 250900298, 250900299, 251740179, 251950033;
Recalling firm:
Mozarc Medical US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0514-2026
Lot/product code:
Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
Recalling firm:
Ajanta Pharma Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in)

Reusable electrodes may not meet expected performance levels.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
98939
Lot/product code:
All Lots: / UDI: TCN-10: 00813250013054; TCN-10-3M: 00813250017502; TCN-15: 00813250013061; TCN-15-3M: 00813250017519; TCN-20: 00813250013078; TCN-20-3M: 00813250017526; TCN-5: 00813250013047; TCN-5-3M:00813250017533
Recalling firm:
Boston Scientific Neuromodulation Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Plum Duo Infusion Pump, 40002-0401

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98872
Lot/product code:
UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0544-2026
Lot/product code:
Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0515-2026
Lot/product code:
Lot#: PA07434, Exp. May 2026.
Recalling firm:
Ajanta Pharma Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98891
Lot/product code:
1. Product Number (CFN): 8888221413; UDI-DI: 10884521788541; Lot numbers: 241620022, 252020038; 2. Product Number (CFN): 8888222416; UDI-DI: 10884521788602; Lot numbers: 241690023, 241830147; 3. Product Number (CFN): 8888221416; UDI-DI: 10884521788558; Lot numbers: 251250041, 251740190, 252020039, 252090031, 253350256; 4. Product Number (CFN): 8888222420; UDI-DI: 10884521788619; Lot numbers: 251740186, 252510026, 253280016; 5. Product Number (CFN): 8888221420; UDI-DI: 10884521788565; Lot numbers: 241620407, 251950032; 6. Product Number (CFN): 8888222424; UDI-DI: 10884521788626; Lot number: 243040007; 7. Product Number (CFN): 8888221424; UDI-DI: 10884521788572; Lot numbers: 241200034, 251250039, 252020037; 8. Product Number (CFN): 8888221430; UDI-DI: 10884521788589; Lot number: 251250042; 9. Product Number (CFN): 8888233413; UDI-DI: 10884521788718; Lot number: 250310009; 10. Product Number (CFN): 8888233416; UDI-DI: 10884521788725; Lot numbers: 250350008, 250690152, 250690153, 250870012, 251010012, 251010013, 251320332, 251320333, 251390368, 251390369, 252580023; 11. Product Number (CFN): 8888233420; UDI-DI: 10884521788732; Lot numbers: 250870013, 250970052, 251320330, 251320331; 12. Product Number (CFN): 8888231420; UDI-DI: 10884521788688; Lot numbers: 241690216, 252020046, 252230023, 252580025; 13. Product Number (CFN): 8888233424; UDI-DI: 10884521788749; Lot numbers: 251740197, 252300054; 14. Product Number (CFN): 8888231424; UDI-DI: 10884521788695; Lot numbers: 251460351, 251740196, 252020045, 252230022, 252580024; 15. Product Number (CFN): 8888231430; UDI-DI: 10884521788701; Lot number: 252730009; 16. Product Number (CFN): 8888231413; UDI-DI: 10884521788664; Lot number: 250310010; 17. Product Number (CFN): 8888231416; UDI-DI: 10884521788671; Lot numbers: 252230021, 252510030, 252650294, 253140280; 18. Product Number (CFN): 8888213416; UDI-DI: 10884521788527; Lot number: 252300325; 19. Product Number (CFN): 8888211416; UDI-DI: 10884521788435; Lot numbers: 241060237, 250830187, 250900067, 251250037, 251430012, 252870014; 20. Product Number (CFN): 8888213420; UDI-DI: 10884521788534; Lot number: 252300051; 21. Product Number (CFN): 8888211420; UDI-DI: 10884521788442; Lot numbers: 241480021, 242390056, 250070005, 250310011, 250310012, 250760180, 250900066, 251250035, 251950034; 22. Product Number (CFN): 8888212413; UDI-DI: 10884521788473; Lot number: 242950260; 23. Product Number (CFN): 8888211413; UDI-DI: 10884521788428; Lot number: 252510028; 24. Product Number (CFN): 8888212416; UDI-DI: 10884521788480; Lot numbers: 243160028, 250760159, 251250036, 251320325; 25. Product Number (CFN): 8888212420; UDI-DI: 10884521788497; Lot numbers: 241350005, 250310006, 251740192, 252160037; 26. Product Number (CFN): 8888211424; UDI-DI: 10884521788459; Lot numbers: 250830185, 250830186, 250900298, 250900299, 251740179, 251950033;
Recalling firm:
Mozarc Medical US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0516-2026
Lot/product code:
Lot#: PA10734, Exp. Jun 2026.
Recalling firm:
Ajanta Pharma Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Plum Solo Precision IV Pump, 40001-0401

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98872
Lot/product code:
UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)