Category

Surgical Devices Recalls

3,817 surgical devices recalls on record from CPSC, FDA, and USDA.

3,817 recalls
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: ...
Surgical Devices·480 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter P...
Surgical Devices·46,828 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Lu...
Surgical Devices·3,470 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with L...
Surgical Devices·23,587 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 ...
Surgical Devices·0 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: f...
Surgical Devices·0 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladde...
Surgical Devices·3,012 affected·Apr 30, 2020
High RiskFDA
Argon Medical Devices, Inc
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introduc...
Surgical Devices·15,795 affected·Apr 26, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Produc...
Surgical Devices·570 affected·Apr 23, 2020
High RiskFDA
Bovie Medical Corporation
Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BP...
Surgical Devices·13,948 affected·Apr 20, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
Philips North America, Llc
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnost...
Surgical Devices·25 affected·Apr 10, 2020
High RiskFDA
Philips North America, Llc
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnost...
Surgical Devices·25 affected·Apr 10, 2020
High RiskFDA
Coopersurgical, Inc.
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Surgical Devices·1,740 affected·Apr 9, 2020
High RiskFDA
Argon Medical Devices, Inc
PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indic...
Surgical Devices·80 affected·Apr 8, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids...
Surgical Devices·88 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or g...
Surgical Devices·60 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids ...
Surgical Devices·31 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·35 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids o...
Surgical Devices·375 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·1,393 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the...
Surgical Devices·379 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·12 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or ga...
Surgical Devices·1,053 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids ...
Surgical Devices·121 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps o...
Surgical Devices·442 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·217 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gap...
Surgical Devices·27 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the...
Surgical Devices·54 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·51 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps o...
Surgical Devices·70 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of ...
Surgical Devices·41 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids ...
Surgical Devices·10 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Usage: Callos is in...
Surgical Devices·661 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·111 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps ...
Surgical Devices·379 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps ...
Surgical Devices·184 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·4 affected·Apr 6, 2020