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.

Agency

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

276–300 of 390

ModerateFDA (Devices)·Z-1959-2026·2026-05-06
Philips Ingenia 3.0T CX MRI System MR Elastography Software Issue
Philips is recalling Ingenia 3.0T CX MRI systems with MR Elastography due to potential stiffness value errors caused by specific image reconstruction parameters and Resoundant algorithm settings, resulting in incorrect voxel size displays in the default MRE scan protocol.
Product
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1998-2026·2026-05-06
Heraeus PALAMIX duo dental mixing system batches worldwide recall
Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.
Product
Heraeus, PALAMIX duo. Material Number: 66057897.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1997-2026·2026-05-06
Heraeus PALAMIX uno Dental Material Mixing Rod Loose Risk Recall
Heraeus Medical is recalling PALAMIX uno dental material because the mixing rod may come loose during mixing in units older than 1.5 years. The shelf life has been reduced from 3 years to 1.5 years.
Product
Heraeus, PALAMIX uno. Material Number: 66057893.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1843-2026·2026-04-29
Control Syringes and Related Devices FDA Regulatory Clearances Rescinded
Medline Industries has recalled Control Syringes (Model DNSC89369 and DYNJSYR10C), Guidewires, and High-Pressure Tubing after their FDA 510(k) regulatory clearances were rescinded. The devices were distributed nationwide.
Product
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1931-2026·2026-04-29
LSL Healthcare Infant Central Line Dressing Change Kit Recalled
LSL Healthcare is recalling its Infant Central Line Dressing Change Kit (Model 2925H) distributed nationwide because it contains Webcol Large Alcohol Prep Pads that were recalled for non-sterility.
Product
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1932-2026·2026-04-29
IV Start Kit with Non-Sterile Alcohol Prep Pads Recalled
LSL Healthcare is recalling IV Start Kits containing Webcol Large Alcohol Prep Pads due to non-sterility concerns. The affected kits were distributed nationwide in Maryland, Illinois, and Minnesota.
Product
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1876-2026·2026-04-29
Medline 10mL Polycarbonate Syringes in Convenience Kits recalled
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The kits were distributed nationwide in the US and to Canada, Panama, and Barbados.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ022088
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1869-2026·2026-04-29
Soft-Vu Angiographic Catheter Recalled Due to Manufacturing Defect
Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter (Straight Art, Non-Braided) units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.
Product
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1834-2026·2026-04-29
Medline angiography and catheter kits subject to rescinded regulatory clearances
Medline Industries is recalling 12 types of angiography and catheter kits because their 510(k) regulatory clearances have been rescinded. The kits were distributed nationwide.
Product
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Nu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1842-2026·2026-04-29
Medline Surgical Kits Recalled Due to Rescinded Regulatory Clearances
Medline Industries is recalling 41 different surgical kit models nationwide because regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded. Affected facilities should stop use and contact Medline.
Product
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1886-2026·2026-04-29
Medline Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes (Eye Pack and Heart Cath Pack) due to unapproved design changes made outside of FDA 510(k) clearance.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1867-2026·2026-04-29
Soft-Vu Angiographic Catheter Soft-Vu SO1 recalled for manufacturing defect
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1892-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes because the products were modified in ways not approved by the FDA. The kits were distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1837-2026·2026-04-29
Medline PICC Tray Model DYNJ41648A regulatory clearance rescinded
Medline Industries has recalled its PICC Tray (Model DYNJ41648A) because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded by FDA.
Product
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1890-2026·2026-04-29
Medline Convenience Kits with 10mL Polycarbonate Colored Syringes Recalled
Medline Industries is recalling multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1844-2026·2026-04-29
Medline medical device kits recalled for regulatory compliance rescission
Medline Industries has recalled six medical device kits (arthrogram trays, angiography packs, and neuro packs) because their 510(k) regulatory clearances have been rescinded by the FDA.
Product
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1891-2026·2026-04-29
Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes recalled
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects multiple product SKUs distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1878-2026·2026-04-29
Medline Convenience Kits with Colored Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling multiple Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects products distributed worldwide including the US, Canada, Panama, and Barbados.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1879-2026·2026-04-29
Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries, LP is recalling Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed worldwide.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1845-2026·2026-04-29
Medline Labor Pack medical device kits regulatory clearance rescinded
Medline Industries is recalling certain Labor Pack kits (Model DYNJ44813D) nationwide because their 510(k) regulatory clearances for Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
Product
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1877-2026·2026-04-29
Medline Convenience Kits With Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects 270,311 units distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ6920
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1912-2026·2026-04-29
Arrow Percutaneous Sheath Introducer Catheter Recall Due to Adhesive Defect
Arrow International is recalling 115 units of its percutaneous sheath introducer with 7.5–8 Fr catheter because the liquid adhesive was incorrectly manufactured by a supplier. The product is used for venous access and central circulation catheterization.
Product
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1854-2026·2026-04-29
Olympus Thunderbeat II Shears Ultrasonic Mode distal tip detachment risk
Olympus is recalling Thunderbeat II Shears (5mm, 45cm) because the distal tip component may detach during use, potentially causing patient harm.
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1933-2026·2026-04-29
LSL Healthcare Wound Closure Tray Model 7554 Recalled for Non-Sterility
LSL Healthcare is recalling its Wound Closure Tray (Model 7554) distributed nationwide to Maryland, Illinois, and Minnesota because the kits contained non-sterile Webcol Large Alcohol Prep Pads.
Product
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2026·2026-04-29
AccuVu Angiographic Catheter recall due to manufacturing defect
Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.
Product
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide

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