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Recalls affecting Alabama

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

16,873 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 Mendietary 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 AliveMoringa 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. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
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 ValueOrganic 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

LipofitLipofit 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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
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 TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
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 SproutsRobust 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

MartinaMangoes

Potential contamination with Salmonella

Full report
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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled May 27, 2026

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.

ALL 50 STATES
Full report

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

Recall #:
99105
Lot/product code:
Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204
Recalling firm:
Inter-Med Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled May 26, 2026

functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2

Weaker than it should be for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.

Full report

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

Recall #:
H-1152-2026
Lot/product code:
24 count case with BEST IF USED BY DATES up to and including March 15, 2028 12 count package BEST IF USED BY DATES up to and including October 7, 2027
Recalling firm:
Nutricia North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 26, 2026

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

ALL 50 STATES
Full report

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

Recall #:
99084
Lot/product code:
UDI/DI 00884838000407, Serial Numbers: DE79569306, DE79569332, DE79569360, DE79569417, DE79569442, DE79569482, DE79569307, DE79569470, DE79569390, DE79569356, DE79569452, DE79569289, DE79569302, DE79569536, DE79569358, DE79569343, DE79569457, DE79569353, DE79569373, DE79569411, DE79569491, DE79569615, DE79569287, DE79569338, DE79569437, DE79569459, DE79569473, DE79569340, DE79569308, DE79569377, DE79569286, DE79569304, DE79569327, DE79569330, DE79569347, DE79569352, DE79569400, DE79569418, DE79569431, DE79569436, DE79569456, DE79569469, DE79569474, DE79569588, DE79569326, DE79569424, DE79569487, DE79569547, DE79569290, DE79569258, DE79569367, DE79569370, DE79569380, DE79569388, DE79569311, DE79569440, DE79569460, DE79569527, DE79569462, DE79569299, DE79569261, DE79569405, DE79569260, DE79569313, DE79569369, DE79569216.
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled May 26, 2026

functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8, package UPC 8 57858 00447 2

Weaker than it should be for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.

Full report

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

Recall #:
H-1153-2026
Lot/product code:
24 count case with BEST IF USED BY DATES up to and including April 14, 2028 12 count package BEST IF USED BY DATES up to and including February 19, 2028
Recalling firm:
Nutricia North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 26, 2026

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

ALL 50 STATES
Full report

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

Recall #:
99084
Lot/product code:
UDI/DI 00884838000414, Serial Numbers: DE79646555, DE79646616, DE79646645, DE79646647, DE79646651, DE79646697, DE79646702, DE79646746, DE79646754, DE79646757, DE79646758, DE79646762, DE79646765, DE79646775, DE79646776, DE79646783, DE79646857, DE79646891, DE79646924, DE79646750, DE79646751, DE79646756, DE79646804, DE79646592, DE79646877, DE79646644, DE79646706, DE79646723, DE79646653, DE79646766, DE79646786, DE79646824, DE79646827, DE79646848, DE79646956, DE79646709, DE79646892, DE79646724, DE79646729, DE79646732, DE79646733, DE79646927, DE79646675, DE79646820, DE79646821, DE79646837, DE79646866, DE79646869, DE79646871, DE79646875, DE79646882, DE79646683, DE79646676, DE79646640, DE79646849, DE79646952, DE79646699, DE79646694, DE79646648, DE79646701, DE79646900, DE79647027, DE79647039, DE79646654, DE79646800, DE79646604, DE79646660, DE79646829, DE79646747, DE79646606, DE79646826, DE79646784, DE79646794.
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled May 25, 2026

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

ALL 50 STATES
Full report

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

Recall #:
99199
Lot/product code:
MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled May 25, 2026

Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

ALL 50 STATES
Full report

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

Recall #:
99199
Lot/product code:
MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled May 24, 2026

MOGO PURE MORINGA OLEIFERA CAPSULES, HERBAL SUPPLEMENT, 180 QUICK RELEASE VEGGIE CAPSULE, 100% PURE, 350 MG PER CAPSULE, SUPPLEMENT FACTS MORINGA POWDER 1050 mg, Ingredients: 100% Pure Moringa Leaf Powder (Moringa Oleifera), MANUFACTURED IN USA AND Marketed by: MOGO MIRINGA LLC, PO BOX 32066 Saint Louis, MO 63132

Product may be contaminated with Salmonella Typhimurium

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1128-2026
Lot/product code:
Lot codes: 15525AA exp date: 6/2027 00926AA exp date: 1/2028
Recalling firm:
MOGO Moringa LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

Potential for thrombus formation during prolonged use of the introducer.

ALL 50 STATES
Full report

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

Recall #:
99002
Lot/product code:
Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

Potential for thrombus formation during prolonged use of the introducer.

ALL 50 STATES
Full report

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

Recall #:
99002
Lot/product code:
1. Impella Set Product Code: 1000413; GTIN: 00813502013566; Serial numbers: 649727, 649728, 649729, 649730, 649731, 654349, 654348, 654342, 654341, 654340, 654339, 654338, 654336, 654335, 654334, 654333, 653010, 653009, 653008, 653007, 653006, 653005, 653004, 653003, 653002, 653001, 655735, 655733, 654357, 654356, 654382, 654383, 654381, 654380, 654378, 654367, 654366, 654364, 654365, 654362, 654363, 654361, 654360, 654359, 654358, 654379, 655734, 654386, 654355, 654385, 654384, 654353, 654352, 654351, 654350, 654387, 657649, 657648, 657646, 657647, 657645, 657644, 655742, 655739, 655741, 655740, 655738, 655737, 655736, 656743, 656738, 653050, 653049, 653048, 653047, 653045, 653044, 653043, 653042, 653041. Introducer Product Code: 2000684; Batch Numbers: 2026724558, 2027818724. 2. Product Code: 1000834. GTIN: 00813502013948. Serial numbers: 653474, 653471, 653485, 653470, 653469, 653468, 653467, 653465, 653466, 653463, 653464, 653482, 653483, 653484, 653481, 653490, 653462, 653478, 653479, 653489, 653488, 653487, 653486, 653476, 653477, 656002, 656001, 656000, 655998, 655997, 655993, 655996, 655995, 655994, 656737, 656736, 656735, 656734, 656733, 656730, 656731, 656729, 656728, 656346, 656343, 656342, 656341, 656340, 656338, 659804, 659795, 656347, 650264, 659801, 659802, 659800, 659799, 659798, 656363, 656367, 656362, 656361, 656360, 656359, 656358, 659794, 659793, 659791, 659792, 659790, 659789, 659788, 659786, 659787, 659785, 661408, 661407, 661405, 661404, 661392, 661391, 661389, 661403, 661402, 661401, 661400, 662657, 662654. Introducer Product Code: 2000785; Batch Numbers: 2026787668, 2027818660. Distributed in Japan.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled May 22, 2026

1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg (120 capsules)

Product may be contaminated with Salmonella.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0942-2026
Lot/product code:
1. Lot: 2507199 Exp. 09/2027 Lot: 2512-304 Exp. 02/2028 Lot: 2793 Exp. 02/2028 Lot: 2748 Exp. 07/2027 ASIN: B0DBRDPBDT, SKU: AB8047, UPC: 095234280472, FNSKU: X004C9XHAL 2. Lot: 2507199 Exp. 09/2027 Lot: 2748 Exp. 07/2027 UPC: 095234698734; SKU: AB9873
Recalling firm:
Total Nutrition Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

Potential for thrombus formation during prolonged use of the introducer.

ALL 50 STATES
Full report

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

Recall #:
99002
Lot/product code:
Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

ALL 50 STATES
Full report

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

Recall #:
99143
Lot/product code:
Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796; Lot Serial No. 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960.
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 22, 2026

Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.

Microbial contamination of sterile products

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-0586-2026
Lot/product code:
Batch # E2612116, Exp Date: April 2029.
Recalling firm:
Zep Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 22, 2026

Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

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-0598-2026
Lot/product code:
Lot #: AD93852, Exp Date: 06/2027.
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.

ALL 50 STATES
Full report

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

Recall #:
99035
Lot/product code:
GTIN: 07630002800839/ Lot # range: 00001 -19732
Recalling firm:
Hamilton Medical AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

ALL 50 STATES
Full report

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

Recall #:
99143
Lot/product code:
Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065.
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 22, 2026

Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

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-0599-2026
Lot/product code:
Lot #: AE11393, Exp Date: 10/2027.
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

ALL 50 STATES
Full report

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

Recall #:
99188
Lot/product code:
LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
Recalling firm:
Innovasis, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

Medtronic Harmony Delivery Catheter System

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

ALL 50 STATES
Full report

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

Recall #:
99031
Lot/product code:
GTIN 00763000341367, Lot Numbers: 0012508285, 0012517045, 0012526102, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663878, 0012663879, 0012690218, 0012699635, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824770, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965210, 0012965211, 0012976400, 0012986693, 0013063766, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624, 0013236643, 0013272796, 0013272798. GTIN 00763000544027, Lot Numbers: 0012508285, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663879, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965211, 0012976400, 0012986693, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624. GTIN 00763000520151, Lot Numbers: 0012575897, 0012642965, 0012728368, 0013272799. GTIN 00763000582951, Lot Numbers: 0012590535, 0012606411, 0012606413, 0012642964, 0012659418, 0012678282, 0012690219, 0012699637, 0012804151, 0012804580, 0012874527, 0012888682, 0012896885, 0012965221, 0012986699, 0013063764, 0013063765, 0013105037, 0013227504. GTIN 00763000918712, Lot Numbers: 0012635392, 0012676200, 0012690207, 0012874528, 0012874529, 0013015539, 0013105038.
Recalling firm:
Medtronic Heart Valves Division
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UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.

Potential for thrombus formation during prolonged use of the introducer.

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

Recall #:
99002
Lot/product code:
Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
Recalling firm:
Abiomed, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

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

Recall #:
99027
Lot/product code:
Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785. 26153EAU/1 seals with expiration date: January 23, 2023.
Recalling firm:
Karl Storz Endoscopy
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UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

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

Recall #:
99119
Lot/product code:
UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Recalling firm:
Baxter Healthcare Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741066054 The Power-Trialysis" Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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

Recall #:
99096
Lot/product code:
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 Lot Number: REKX1755 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 Lot Number: REKW0663 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 Lot Number: REKY2472 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 Lot Number: REKZ0393 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKQ1130 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKX3745 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 Lot Number: REKY2418 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741066054 Lot Number: REKY2420
Recalling firm:
Bard Access Systems, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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Full report

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

Recall #:
99096
Lot/product code:
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741087110 Lot Number: REKW2449 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741027536 Lot Number: REKV2227
Recalling firm:
Bard Access Systems, Inc.
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