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

176–200 of 247

HighFDA (Devices)·Z-2030-2026·2026-05-06
Medline Microdisectomy Kits Recalled for High Endotoxin Levels
Medline is recalling Microdisectomy Packs containing Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review. The affected products may be out-of-specification for endotoxin.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2023-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline Industries is recalling three medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels identified during internal review. The affected kits may be out-of-specification for endotoxin.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ90836
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1991-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral Knee Component Recall
Depuy Synthes is recalling 3 units of the ATTUNE Revision Hinge Femoral (Right, Size 5, Cemented) knee implant due to external sterile packaging adhered to internal sterile packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1999-2026·2026-05-06
Abbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
Abbott Point Of Care is recalling approximately 7.6% of specific i-STAT EG7+ cartridge lots due to a manufacturing issue causing falsely high pCO2 and low pH readings. Inaccurate results could lead clinicians to make unnecessary or harmful medical interventions.
Product
i-STAT EG7+ cartridge; List Number: 03P76-25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1987-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2026·2026-05-06
Medline medical procedure kits recalled for elevated endotoxin levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels found on the products. Affected kits were distributed worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2011-2026·2026-05-06
Medline medical procedure kits recalled for out-of-specification endotoxin levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges for spinal fusion due to higher-than-expected endotoxin levels that may be out-of-specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2038-2026·2026-05-06
Medline Medical Procedure Kits Recalled for High Endotoxin Levels
Medline is recalling certain medical procedure kits containing neuro sponges because they may have higher-than-expected endotoxin levels, indicating out-of-specification product in the market.
Product
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Category
Medical Device
Distribution
0 states
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

Filters

176–200 of 247