Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 751 - 775 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.	FDA Z-1897-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 9, 2026	Details
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches; 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.	FDA Z-1857-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 3, 2026	Details
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches; 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.	FDA Z-1861-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 3, 2026	Details
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.	FDA Z-1923-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 25, 2026	Details
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.	FDA Z-1832-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 25, 2026	Details
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants	FDA Z-1927-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 20, 2026	Details
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 DYNJ44123C NON VASCULAR PACK DYNJ68037B, DYNJ68037C PICC ABSCESS PACK-LF DYNJ0774005G PICC LINEPACK (PCLUI)642-LF DYNJ47717B PICC PHC DYNJ37484C Unapproved design changes to the products outside of the 510(k) clearance.	FDA Z-1891-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 27, 2026	Details
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ar Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured	FDA Z-1917-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 11, 2026	Details
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).	FDA Z-1919-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 11, 2026	Details
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.	FDA Z-1904-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 25, 2026	Details
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks. Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured	FDA Z-1910-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 11, 2026	Details
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches; 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.	FDA Z-1874-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 3, 2026	Details
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches; 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.	FDA Z-1865-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 3, 2026	Details
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.	FDA Z-1837-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 25, 2026	Details
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; 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.	FDA Z-1867-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 3, 2026	Details
The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm. In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.	FDA Z-1807-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 6, 2026	Details
Flamingo Funnel Large, Model Number SQ20012-03 Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.	FDA Z-1926-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 16, 2026	Details
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; 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.	FDA Z-1869-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 3, 2026	Details
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.	FDA Z-1941-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 18, 2026	Details
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.	FDA Z-1939-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 18, 2026	Details
The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm. In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.	FDA Z-1808-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 6, 2026	Details
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.	FDA Z-1899-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 25, 2026	Details
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.	FDA Z-1931-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 9, 2026	Details
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 DYNJ17218S, DYNJ17218T ARTERIOGRAM NEURO PACK-LF DYNJ0842499L ARTERIOGRAM PACK-LF DYNJ0842478M CARDIAC CATH II PK DYNJ21259O CARDIAC CATH PACK DYNJ68653D CATH LAB ANGIOGRAPHY PACK DYNJ50779G CATH LAB-LF DYNJ51423G CRANIOTOMY PACK-LF DYNJ0101292I DEEP BRAIN STIMULATION PACK DYNJ0842793I ENDO VASCULAR MINOR DYNJ87263 GENERAL ENDO PACK-LF DYNJ08 Unapproved design changes to the products outside of the 510(k) clearance.	FDA Z-1890-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 27, 2026	Details
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.	FDA Z-1843-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 25, 2026	Details

Showing 751 - 775 of 1,678 product recalls

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Medical Device Recalls Today

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