Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

26–50 of 5048

SevereFDA (Drugs)·D-0690-2026·2026-07-22
ChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators nationwide because affected units may have open or incomplete seals on the packaging, which could compromise sterility assurance.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2723-2026·2026-07-22
ICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
ICU Medical is recalling Plum Duo Infusion Pump v1.2.3 units due to a software defect that may cause the pump to deliver up to twice the programmed volume without decrementing the display, risking patient overdose.
Product
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2681-2026·2026-07-22
ABIOMED Impella RP Flex heart pump introducer sheath leakage risk
Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.
Product
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2688-2026·2026-07-22
Abiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk
Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.
Product
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-1171-2026·2026-07-22
D'Dioses Mango Ice Pops Recalled for Undeclared Allergens
D'Dioses Mango Ice Pops (3.7 oz) are being recalled because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these ingredients should not consume the product.
Product
Ice Pop, D'Dioses Mango, 3.7 oz (81.7 g), with UPC 827912008494
Category
Food
Distribution
4 states
SevereFDA (Food)·H-1167-2026·2026-07-22
D'Dioses Cookies Cream Ice Pops Recalled for Undeclared Allergens
D'Dioses Cookies Cream Ice Pops may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. The product was distributed in NJ, CT, NY, and PA.
Product
Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362
Category
Food
Distribution
4 states
SevereFDA (Food)·H-1159-2026·2026-07-22
D'Dioses Fresa Leche Ice Pop Recalled for Undeclared Allergens
D'Dioses Fresa Leche ice pops may contain undeclared milk, pecans, pistachios, and food colorings (yellow #5 and red #40). The product was distributed in NJ, CT, NY, and PA.
Product
Ice Pop, D'Dioses Fresa Leche, 4 oz (85 g), with UPC 710594511850
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-2707-2026·2026-07-22
T-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did not meet sterility release criteria.
Product
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2739-2026·2026-07-22
Medtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
Medtronic is recalling its Bio-Medicus Adult Cannula Kit (Product Number 96530-115) used in cardiopulmonary bypass procedures due to the discovery of loose foreign material containing trace levels of blood in two units.
Product
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2709-2026·2026-07-22
Bone Marrow Tray kits recalled due to sterility failure
Argon Medical Devices is recalling Bone Marrow Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria.
Product
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2704-2026·2026-07-22
Transvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
Argon Medical Devices is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F because kits containing Lidocaine HCL Injection USP did not meet sterility release criteria.
Product
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2680-2026·2026-07-22
Abiomed Impella Introducer Kit recalled for potential fluid leakage
Oscor Inc. is recalling the Abiomed Impella Hemostatic Peel Away Introducer System (23F) due to manufacturing defects that may cause leakage from the sidearm, under the sheath cap, or along the hub region.
Product
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2679-2026·2026-07-22
Abiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
Oscor Inc. is recalling Abiomed introducer kits due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak. The recall affects approximately 1,332 units distributed in Massachusetts.
Product
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2682-2026·2026-07-22
ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.
Product
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-1157-2026·2026-07-22
WY Duck Sauce packets recalled due to potential metal fragments
W.Y. Industries, Inc. is recalling WY Duck Sauce packets because the product may contain metal fragments. The recall affects 1,120 cases distributed to New York, New Jersey, Ohio, and Pennsylvania.
Product
WY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case.
Category
Food
Distribution
4 states
SevereFDA (Food)·H-1162-2026·2026-07-22
Ice Pop D'Dioses Guayaba recalled for undeclared allergens
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Guayaba ice pops because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these ingredients should not consume the product.
Product
Ice Pop, D'Dioses Guayaba, 1 Bar (81.7 g), with UPC 827912008432
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-2708-2026·2026-07-22
Arterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
Argon Medical Devices is recalling an Arterial Line Kit containing Lidocaine HCL Injection USP because the kits do not meet sterility release criteria, creating a risk of infection from non-sterile medical injection.
Product
Arterial Line Kit 20ga x 6, REF: 400115A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-1158-2026·2026-07-22
D'Dioses Coconut Ice Pop Recall Due to Undeclared Allergens
D'Dioses Coconut Ice Pops (4 oz) may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these substances should not consume the product.
Product
Ice Pop, D'Dioses Coconut, 4 oz (85 g), with UPC 710594511867
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-2686-2026·2026-07-22
ABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
Abiomed, Inc. is recalling ABIOMED Impella CP Introducer Kit 14 Fr units worldwide due to potential introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable.
Product
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2683-2026·2026-07-22
ABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall
ABIOMED Impella CP Introducer Kit 14Fr is being recalled due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
Product
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2720-2026·2026-07-22
Olympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
Olympus Corporation of the Americas is recalling the Olympus Ellik Evacuator (Model 194) worldwide because certain sterilization parameters in the instructions may not render the device adequately sterile.
Product
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2705-2026·2026-07-22
One-Piece Introducer Tray kits recalled for sterility failure
Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.
Product
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2687-2026·2026-07-22
ABIOMED Impella 5.5 Heart Pump Introducer Sheath Leakage Risk Recall
Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.
Product
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-1173-2026·2026-07-22
Ice Pop D'Dioses Nanche Recalled for Undeclared Allergens
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Nanche ice pops because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. The product was distributed in NJ, CT, NY, and PA.
Product
Ice Pop, D'Dioses Nanche, 1 Bar (81.7 g), with UPC 827912008449
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-2685-2026·2026-07-22
Abiomed Impella CP Introducer Kit heart pump accessory recall
Abiomed is recalling Impella CP Introducer Kits worldwide due to potential leakage from the introducer sheath that cannot be visually detected by users. The manufacturing defect affects 1,540 units across multiple countries.
Product
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide