Class I - Dangerous
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Class I - Dangerous
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Class I - Dangerous
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Baxter Healthcare
Class I - Dangerous
Product is mislabeled as self-righting Luer slip tip caps, yellow.
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Cardinal Health 200
Class I - Dangerous
Product was distributed without being sterilized.
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Nextremity Solutions
Class I - Dangerous
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Nextremity Solutions
Class I - Dangerous
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
Nextremity Solutions
Class I - Dangerous
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
Nextremity Solutions
Class I - Dangerous
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
Nextremity Solutions
Class I - Dangerous
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
BenchMark ULTRA and DISCOVERY ULTRA Instruments
Ventana Medical Systems
Class I - Dangerous
Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Avanos Medical
Class I - Dangerous
Product was distributed with incorrect expiration date.
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Avanos Medical
Class I - Dangerous
Product was distributed with incorrect expiration date.
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Ansell Healthcare Products
Class I - Dangerous
Transport company failed to stop at the border for required FDA inspection.
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Avanos Medical
Class I - Dangerous
Product was distributed with incorrect expiration date.
EasyFuse Dynamic Compression System Instrument Pack
Wright Medical Technology
Class I - Dangerous
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
Class I - Dangerous
Potential exposure to rodents and rodent activity in the distribution center.
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.