Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

3701–3725 of 13449

HighFDA (Devices)·Z-1224-2025·2025-03-05
A.L.P.S. mvX Medial Tibia Plate Locking Screw Malfunction Recall
Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.
Product
A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1233-2025·2025-03-05
Clinical Chemistry Analyzer Fails to Track Assay Expiration Dates After Software Update
A software issue in the DxC 500 AU analyzer prevents correct tracking of assay expiration dates after software upgrades. Expired assays may be used, potentially producing inaccurate patient test results.
Product
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1234-2025·2025-03-05
Socrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
Scientia Vascular is recalling 120 Socrates 38 Aspiration Catheters due to manufacturing defects that created channels in the packaging seal. The defect could potentially compromise the sterile barrier on devices used for acute stroke treatment.
Product
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1211-2025·2025-03-05
Tyber Medical recalls A.L.P.S. mvX Anatomic Lateral Fibula Plates due to screw malposition
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates (418 units, nationwide) because the locking screw may pass through the locking hole during surgery, causing surgical delays.
Product
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2025·2025-03-05
Orthopedic fibula plate locking screw failure during surgery
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to locking screw passing through the locking hole intra-operatively, causing surgical delays. The recall affects 397 units distributed nationwide.
Product
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2025·2025-03-05
Anatomic Lateral Fibula Plate recalled for locking screw malfunction
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to reports of locking screws passing through the locking hole during surgery, causing surgical delays.
Product
A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1225-2025·2025-03-05
Medical plate locking screw may fail during fracture surgery
A locking screw in the A.L.P.S. mvX Medial Tibia Plate may pass through its locking hole during surgery. Surgical delays have been reported with this device.
Product
A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715161
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1227-2025·2025-03-05
BD PYXIS MEDBANK systems operating room contraindication labeling update
BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.
Product
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1229-2025·2025-03-05
BD PYXIS medication cabinets labeling update: operating room contraindication
CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.
Product
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1228-2025·2025-03-05
BD PYXIS MEDBANK Medication Systems: Labeling Update for Operating Room Restriction
CareFusion is updating labeling for BD PYXIS MEDBANK medication systems to include a contraindication against use in procedure and operating rooms. Healthcare facilities should review updated labeling and ensure appropriate device placement.
Product
155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1248-2025·2025-03-05
Medical device recall: sterilization validator with incorrect incubation time
TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.
Product
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1152-2025·2025-02-26
Philips Allura Xper Patient Table Mattress Defect Fall Risk
Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.
Product
Allura Xper FD10C; Catalog number: 722001
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1070-2025·2025-02-26
Vascular Tack Endovascular System recalled for deployment and migration risks
Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.
Product
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 15613
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1144-2025·2025-02-26
Allura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk
Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.
Product
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1158-2025·2025-02-26
Philips Azurion 7 B20 imaging system patient fall hazard from table mattress
Philips Azurion 7 B20 imaging systems are recalled because the patient table mattress may allow patients to fall. This FDA Class I recall affects 1,314 units distributed worldwide.
Product
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1155-2025·2025-02-26
Philips Azurion 5 M12 Patient Table Recalled for Fall Risk
Philips Medical Systems is recalling Azurion 5 M12 imaging tables due to a mattress defect that could allow patients to fall from the table.
Product
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1154-2025·2025-02-26
Philips Azurion 3 M15 Patient Tables Recalled for Patient Fall Risk
Philips recalls Azurion 3 M15 imaging tables due to mattress defects that could cause patients to fall from the examination table.
Product
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1161-2025·2025-02-26
Philips Allura Centron patient table mattress defect poses fall risk
Philips is recalling Allura Centron patient examination tables due to a mattress defect that poses a fall risk. Eighty units have been distributed internationally.
Product
Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1148-2025·2025-02-26
Philips Allura Xper FD20/10 Imaging System Patient Table Mattress Fall Risk
Philips is recalling the Allura Xper FD20/10 imaging system due to a defect in the patient table mattress that could allow patients to fall during procedures. The Class I recall affects 87 units distributed globally, including 22 in the US.
Product
Allura Xper FD20/10; Catalog numbers: 722029
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1153-2025·2025-02-26
Philips Azurion 3 M12 Medical Table Recalled for Patient Fall Risk
Philips is recalling Azurion 3 M12 patient tables due to possibility of patient falling from the table related to the mattress. The recall affects 263 units distributed in the US and internationally.
Product
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1149-2025·2025-02-26
Philips recalls Allura patient table mattress due to fall hazard
Philips is recalling Allura Xper patient table mattresses because a defect could cause patients to fall. The recall involves 302 units distributed globally.
Product
Allura Xper FD20/15; Catalog numbers: 722058
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1147-2025·2025-02-26
Operating room table recalled due to mattress-related patient fall risk
Philips Allura Xper FD20 OR Table units (catalog numbers 722023, 722035) are recalled due to a mattress defect that could cause patients to fall during procedures.
Product
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1160-2025·2025-02-26
Azurion 7 M20 Patient Tables Recalled for Patient Fall Risk
Philips recalls Azurion 7 M20 patient tables due to a mattress defect that could cause patients to fall. Approximately 1,480 units in the US and 2,741 units overseas are affected.
Product
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1143-2025·2025-02-26
Philips Allura Xper Fluoroscopy Device Patient Table Mattress Fall Risk
Philips Medical is recalling certain Allura Xper FD10/10 fluoroscopy systems because the patient table mattress could cause patients to fall during procedures. The recall affects devices worldwide.
Product
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1146-2025·2025-02-26
Surgical Operating Table Recalled Due to Patient Fall Risk
Philips Medical Systems is recalling the Allura Xper FD20 Biplane OR Table due to a mattress defect that could cause patients to fall during surgery. 3 units are affected globally.
Product
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Category
Medical Device
Distribution
Distributed nationwide

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3701–3725 of 13449