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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

Philips North America

Class I - Dangerous

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Apr 14, 2026 Other Medical Devices Nationwide View Details →

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU DYNJ51677B; 5. RHINO/SEPTO/FESS PACK, Medline Kit Number/SKU DYNJ55955C; 6. NASAL PACK, Medline Kit Number/SKU DYNJ67789A.

Medline Industries

Class I - Dangerous

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Mar 19, 2026 Other Medical Devices View Details →

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.

Medline Industries

Class I - Dangerous

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Mar 19, 2026 Other Medical Devices View Details →

i-STAT EG7+ cartridge; List Number: 03P76-25;

Abbott Point Of Care

Class I - Dangerous

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

Apr 1, 2026 Other Medical Devices Nationwide View Details →

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 DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYBRID-M DYNJ907758D, DYNJ907758F PACEMAKER DYNJ907960C PACEMAKER PACK DYNJ42557B DYNJ61411 DYNJ61411A DYNJ61411B DYNJ80160 PACER PACK DYNJ40952B PERIPHERAL ARTERIOGRAM RAD DYNJ61383B RADIOLOGY PACK DYNJ54762D TAVR PACK DYNJ55338B DYNJ69246A VASCULAR ACCESS TRAY DYNJ52606F VASCULAR TRAY DYNJ49802C VEIN PACK DYNJ57512 DYNJ58063 DYNJ84953

Medline Industries

Class I - Dangerous

Unapproved design changes to the products outside of the 510(k) clearance.

Feb 27, 2026 Implants & Prosthetics Nationwide View Details →

Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108; 6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104; 7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113; 8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103; 9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L; 10) GDWIRE .035INX180CM 3MMJ LT, Model Number: DYNJGWIRE03L; 11) GWIRE HYDRO 0.035 150CM STR S, Model Number: DYNJHWIRE112; 12) GWIRE HYDRO 0.035 180CM STR, Model Number: DYNJHWIRE109; 13) GWIRE HYDRO 0.035 210CM ANGLE, Model Number: DYNJHWIRE102; 14) GWIRE HYDRO 0.035 210CM ANG S, Model Number: DYNJHWIRE106; 15) GWIRE HYDRO 0.035 210CM STR, Model Number: DYNJHWIRE110; 16) GWIRE,HYDRO,0.038,180CM,ANG S, Model Number: DYNJHWIRE121; 17) GWIRE HYDRO 0.038 210CM ANG S, Model Number: DYNJHWIRE122; 18) GWIRE HYDRO 0.038 210CM ANGLE, Model Number: DYNJHWIRE118; 19) GWIRE HYDRO 0.038 260CM STR, Model Number: DYNJHWIRE127; 20) GWIRE,HYDRO,0.038,210CM,STR S, Model Number: DYNJHWIRE130; 21) GWIRE,HYDRO,0.038,260CM,ANG S, Model Number: DYNJHWIRE123; 22) GWIRE,HYDRO,0.038",150CM,STR, Model Number: DYNJHWIRE124; 23) GWIRE HYDRO 0.038 150CM ANGLE, Model Number: DYNJHWIRE116; 24) GWIRE,HYDRO,0.038",210CM,STR, Model Number: DYNJHWIRE126; 25) GWIRE HYDRO 0.035 260CM STR, Model Number: DYNJHWIRE111; 26) GWIRE HYDRO 0.035 150CM ANGLE, Model Number: DYNJHWIRE100; 27) GWIRE HYDRO 0.035 180CM ANGLE, Model Number: DYNJHWIRE101; 28) GWIRE,HYDRO,0.038",180CM, STR, Model Number: DYNJHWIRE125; 29) GWIRE HYDRO 0.038 260CM ANGLE, Model Number: DYNJHWIRE119; 30) GWIRE HYDRO 0.038 150CM ANG S, Model Number: DYNJHWIRE120

Medline Industries

Class I - Dangerous

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Feb 25, 2026 Other Medical Devices Nationwide View Details →

AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;

Angiodynamics

Class I - Dangerous

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

Mar 3, 2026 Surgical Instruments Nationwide View Details →