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.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
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.
Class I - Dangerous
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
Nextremity Solutions
Class I - Dangerous
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Nextremity Solutions
Class I - Dangerous
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
Class I - Dangerous
There is a potential to leak from the catheter where it connects to the drain bag