RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,559 total recalls

nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosi

Landauer

MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511

MEDLINE INDUSTRIES, LP - Northfield

Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

Atrium Medical Corporation

11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016);

Karl Storz Endoscopy

Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I

Applied Medical Technology Inc

Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabi

C.R. Bard Inc

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit

LSL Healthcare Inc.

ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

Covidien

VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

Biomerieux Inc

Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instru

Intuitive Surgical, Inc.

Food Intolerance Test Small

GET TESTED INTERNATIONAL AB

IntelliVue MP30. Product Number: M8002A.

Philips North America Llc

TRANSDUCER L12-5 Transducer Probe

Philips Ultrasound, Inc

Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708

Trinity Sterile, Inc.

OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administra

B. Braun Medical, Inc.

UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

Beckman Coulter Inc.

Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Contr

Abiomed, Inc.

Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device

Carefusion 2200 Inc

ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision

DePuy Orthopaedics, Inc.

Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G009

Cook Incorporated

See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERN

Medline Industries, LP

nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring do

Landauer

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis

Baxter Healthcare Corporation

PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012

Biomerieux Inc

FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712

Mckesson Medical-Surgical Inc. Corporate Office

Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063

MEDLINE INDUSTRIES, LP - Northfield

Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation

Sensus Healthcare, Inc.

AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusio

Aesculap Implant Systems LLC

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13

Linkbio Corp.

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