Locking Cap for PD Catheter Adapter
Baxter Healthcare
Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Intuitive Surgical
Class I - Dangerous
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
Medtronic Perfusion Systems
Class I - Dangerous
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Surgical Suture Kit
Stradis Healthcare
Class I - Dangerous
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
MicroScan WalkAway-40 plus Instrument REF B1018-283
Beckman Coulter
Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Beckman Coulter
Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Beckman Coulter
Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Turbett Surgical Container, TS1500
TURBETT SURGICAL
Class I - Dangerous
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
MicroScan WalkAway-96 plus Instrument REF B1018-284
Beckman Coulter
Class I - Dangerous
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular
Class I - Dangerous
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Class I - Dangerous
Patient chart label contains incorrect Part Number and volume amount.
Class I - Dangerous
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Class I - Dangerous
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Class I - Dangerous
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Class I - Dangerous
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Class I - Dangerous
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.