Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

301–325 of 390

HighFDA (Devices)·Z-1866-2026·2026-04-29
Angiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2026·2026-04-29
[pending] Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Co
Pending LLM rewrite. Source: FDA_DEVICE Z-1883-2026.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1894-2026·2026-04-29
LeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up testing.
Product
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Contro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1859-2026·2026-04-29
[pending] Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.
Pending LLM rewrite. Source: FDA_DEVICE Z-1859-2026.
Product
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1836-2026·2026-04-29
[pending] Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAP
Pending LLM rewrite. Source: FDA_DEVICE Z-1836-2026.
Product
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1907-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Failure Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1856-2026·2026-04-29
Soft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub's inner diameter.
Product
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1853-2026·2026-04-29
[pending] Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Pending LLM rewrite. Source: FDA_DEVICE Z-1853-2026.
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1941-2026·2026-04-29
Diversatek Viper Wire Guided Balloon Dilator Inflation Tag Incorrect
Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the attached inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.
Product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1930-2026·2026-04-29
Foley Urine Collection Kit recalled for non-sterile alcohol prep pads
LSL Healthcare is recalling its Foley Urine Collection Kit (Model 1555) because it contains Webcol Large Alcohol Prep Pads that are non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.
Product
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1922-2026·2026-04-29
Beckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.
Product
Access Total T4 Calibrator, Catalog No. 33805
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1916-2026·2026-04-29
[pending] MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI c
Pending LLM rewrite. Source: FDA_DEVICE Z-1916-2026.
Product
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1906-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2118) due to potential premature failure of Version 2 reprocessor connecting tube lock levers. The recall affects 1,259 units distributed worldwide.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2026·2026-04-29
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided recalled for manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The defect affects 1,550 units distributed worldwide.
Product
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1860-2026·2026-04-29
Soft-Vu Angiographic Catheter Angiodynamics Guidewire Passage Defect
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The catheters were distributed worldwide including the US.
Product
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2026·2026-04-29
AccuVu Angiographic Catheter Manufacturing Defect Recall Worldwide
Angiodynamics is recalling AccuVu Angiographic Catheters worldwide due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.
Product
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;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2026·2026-04-29
Soft-Vu Angiographic Catheter Kumpe Non-Braided manufacturing defect recall
Angiodynamics is recalling Soft-Vu Angiographic Catheter Kumpe units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
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;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1927-2026·2026-04-29
Sequencing Agent SEQ0067 Component Recalled for Potential False-Positive Results
Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx test, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants.
Product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1861-2026·2026-04-29
Angiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
Angiodynamics is recalling specific lots of Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.
Product
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;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1851-2026·2026-04-29
Olympus Thunderbeat II Shears recall due to distal tip detachment
Olympus Corporation of the Americas is recalling Olympus Thunderbeat II Shears (Model TB2-0520FC) because the distal tip component may detach during use.
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1896-2026·2026-04-29
Avitene Ultrafoam Microfibrillar Collagen Hemostat Recalled for Foreign Matter
Davol, Inc. is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog Number 1050030) because the product may contain foreign matter, confirmed to be inspect fragments.
Product
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1808-2026·2026-04-29
Handheld UV-C germicidal wand recalls for excessive radiation exposure
Uvlizer handheld UV-C germicidal wands may expose users and nearby people to ultraviolet radiation at levels above international safety guidelines for skin and eye protection.
Product
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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1870-2026·2026-04-29
Soft-Vu Angiographic Catheter Omni Flush Non-Braided Defect Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Omni Flush, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1862-2026·2026-04-29
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1920-2026·2026-04-29
IV Administration Sets from Windstone Medical for Infusion Pump Systems
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit units due to potential backflow of medication between IV containers and risk of priming failure in gravity and pump administration sets.
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Category
Medical Device
Distribution
Distributed nationwide

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