Medical device recalls

39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.

2018-12-12FDA-DevicePhilips Medical Systems (Cleveland) IncClass II
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceZimmer Biomet, Inc.Class II
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
2018-12-12FDA-DeviceHelena Laboratories, Inc.Class III
Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.
Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
2018-12-12FDA-DeviceBecton Dickinson & Co.Class II
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
2018-12-12FDA-DeviceBarco N.V.Class II
Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
If metal strips are removed and re-applied to another display, there is potential for the metal strips to be deformed resulting in a smaller contact surface with the front cover magnet strips. There is a risk that the protective front cover could come loose and may fall down.
2018-12-12FDA-DeviceNeomed IncClass III
NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tu
The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date
2018-12-12FDA-DeviceASO, LLCClass II
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
Potential that gauze pads may not be fully sterilized
2018-12-12FDA-DeviceGE Healthcare, LLCClass I
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
2018-12-05FDA-DeviceGE Healthcare, LLCClass II
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
2018-12-05FDA-DeviceGE Healthcare, LLCClass II
Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
2018-12-05FDA-DeviceGE Healthcare, LLCClass II
Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
2018-12-05FDA-DeviceGE Healthcare, LLCClass II
Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
2018-12-05FDA-DeviceGE Healthcare, LLCClass II
Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
2018-12-05FDA-DeviceGE Healthcare, LLCClass II
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
2018-12-05FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass III
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Discolored powder has confirmed the presence of a foreign substance
2018-12-05FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass III
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Discolored powder has confirmed the presence of a foreign substance
2018-12-05FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass III
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Discolored powder has confirmed the presence of a foreign substance
2018-12-05FDA-DeviceEUROTROL INCClass II
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems.
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

← prevpage 688/1308next →

Get notified about new device recalls

Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.

Get the Sunday Brief

Get notified about new device recalls

Explore other recall topics