Category
Surgical Devices Recalls
3,817 surgical devices recalls on record from CPSC, FDA, and USDA.
3,817 recalls
High RiskFDA
Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30...
Surgical Devices23,904 affectedNov 27, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days...
Surgical Devices23,904 affectedNov 27, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: ...
Surgical Devices23,904 affectedNov 27, 2017
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC...
Surgical Devices23,904 affectedNov 27, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 ...
Surgical Devices23,904 affectedNov 27, 2017
High RiskFDA
Ethicon, Inc.
DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold clos...
Surgical Devices20,090 affectedNov 27, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central ...
Surgical Devices23,904 affectedNov 27, 2017
High RiskFDA
Arrow International Inc
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central ve...
Surgical Devices23,904 affectedNov 27, 2017
High RiskFDA
United Orthopedic Corporation
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indic...
Surgical Devices69 affectedNov 24, 2017
High RiskFDA
United Orthopedic Corporation
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthr...
Surgical Devices14 affectedNov 24, 2017
RecallFDA
Ecolab Inc
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/...
Surgical Devices65 affectedNov 22, 2017
High RiskFDA
Medical Components, Inc Dba Medcomp
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Surgical Devices24 affectedNov 22, 2017
RecallFDA
Ecolab Inc
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons...
Surgical Devices65 affectedNov 22, 2017
High RiskFDA
Z-medica, Llc
QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may...
Surgical Devices4,890 affectedNov 17, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrie...
Surgical Devices18,124 affectedNov 14, 2017
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for u...
Surgical Devices18,124 affectedNov 14, 2017
High RiskFDA
Amendia, Inc Dba Spinal Elements
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization...
Surgical Devices82 affectedNov 13, 2017
High RiskFDA
Vascular Insights, Llc
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion ...
Surgical Devices928 affectedNov 9, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the p...
Surgical Devices25,400 affectedNov 6, 2017
High RiskFDA
Southmedic, Inc.
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping...
Surgical Devices3,300 affectedNov 6, 2017
High RiskFDA
Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ...
Surgical Devices2 affectedNov 3, 2017
High RiskFDA
Madison Polymeric Engineering
First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instru...
Surgical Devices285 affectedNov 3, 2017
High RiskFDA
Stryker Neurovascular
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Mi...
Surgical Devices1 affectedNov 3, 2017
High RiskFDA
Beaver-visitec International Inc.
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usag...
Surgical Devices45 affectedNov 3, 2017
High RiskFDA
Beaver-visitec International Inc.
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: ...
Surgical Devices572,490 affectedNov 3, 2017
High RiskFDA
Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS ...
Surgical Devices2 affectedNov 3, 2017
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04220
Surgical Devices6,358 affectedOct 26, 2017
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04020
Surgical Devices50,263 affectedOct 26, 2017
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04122
Surgical Devices570 affectedOct 26, 2017
High RiskFDA
Centurion Medical Products Corporation
CATHETER SECUREMENT SYSTEM
Surgical Devices0 affectedOct 23, 2017
High RiskFDA
Medline Industries Inc
Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Surgical Devices8,000 affectedOct 23, 2017
High RiskFDA
Alto Development Corp
Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue ...
Surgical Devices411,486 affectedOct 23, 2017
High RiskFDA
Cook Inc.
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastro...
Surgical Devices615 affectedOct 19, 2017
High RiskFDA
Cook Inc.
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Surgical Devices1 affectedOct 19, 2017
High RiskFDA
Cook Inc.
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Surgical Devices1 affectedOct 19, 2017
High RiskFDA
Bioseal Corporation
Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309...
Surgical Devices51,635 affectedOct 18, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code...
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Arrow International Inc
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-C...
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Arrow International Inc
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Arrow International Inc
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Arrow International Inc
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Featur...
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 201...
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Arrow International Inc
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. D...
Surgical Devices5,926 affectedOct 17, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Inci...
Surgical Devices5,946 affectedOct 16, 2017
High RiskFDA
Medtronic Minimally Invasive Therapies Group
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Surgical Devices0 affectedOct 14, 2017
High RiskFDA
Ecolab, Inc.
Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 ...
Surgical Devices5,958 affectedOct 13, 2017