Class I - Dangerous
Manufacturing flaw in the sterile barrier system
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
ROi Consolidated Service Center (CSC)
Class I - Dangerous
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
Medical Components, Inc
Class I - Dangerous
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
ROi Consolidated Service Center (CSC)
Class I - Dangerous
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
Lasers/Catheters did not calibrate during set-up prior to use.
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
Medical Components, Inc
Class I - Dangerous
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Class I - Dangerous
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
Medical Components, Inc
Class I - Dangerous
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Acuject Variable Injection Needle
Wilson-Cook Medical
Class I - Dangerous
Potential for occluded injection needles.
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Encore Medical
Class I - Dangerous
Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.
Class I - Dangerous
Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Terumo Medical
Class I - Dangerous
There is a potential for a loss of package integrity that may compromise the sterility of the product.
Terumo Needle, 23G x 1", Product Code NN2325R
Terumo Medical
Class I - Dangerous
There is a potential for a loss of package integrity that may compromise the sterility of the product.
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Terumo Medical
Class I - Dangerous
There is a potential for a loss of package integrity that may compromise the sterility of the product.
3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Becton Dickinson & Company
Class I - Dangerous
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
Cardinal Health 200
Class I - Dangerous
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
Cardinal Health 200
Class I - Dangerous
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Monoject Standard Hypodermic Needle Item code: 8881200029
Cardinal Health 200
Class I - Dangerous
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
Cardinal Health 200
Class I - Dangerous
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product