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FDA Device Enforcement Reports

View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.

FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.

ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Enforcement
Class I ·Terminated·Customed, Inc·September 10, 2014

OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

FDA Enforcement
Class II ·Terminated·GE OEC Medical Systems, Inc·July 25, 2012

SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11 (1) BULB SYRINGE 60cc (1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18" X 18" XRD (2) U-DRAPE 60" X 70" WITH TAPE SPLIT (2) DRAPE SHEET 41" X 58" SMS (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TABLE COVER REINFORCED 50" X 90" (1) COBAN WRAP TAN 4" X 5yds (1) TIME OUT BEACON NON WOVEN (2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV (2) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK WITH 8 LABEL (1) TUBE CONNECTING SUCTION X" X 12' (1) MAYO TRAY SMALL ( 1) CAMERA COVER W/ELAST. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Enforcement
Class I ·Terminated·Customed, Inc·September 10, 2014

Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·August 17, 2016

STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·December 31, 2014

0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (1) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) BOWL PLASTIC WITH LID 80oz LIF (1) RECEIVING BLANKET 100% COTTON (1) BABY BLANKET IMPERVIOUS POLY ABS. LIF (1) UMBILICAL CORD CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) UTILITY BOWL 16oz LIF (2) TRAY ORGANIZER FULL DEEP (3) ABSORBENT TIP APPLICATOR (2) GLOVE EXAM MEDIUM (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP (10) GAUZE SPONGE 4" X 4" 12PLY (2) PAD OBSTETRICAL X-LARGE ST. LIF (1) EAR ULCER SYRINGE 2oz UF (1) BABY BEANNIES (2) DRAPE SHEET 41 " X 58" SMS (1) SCISSORS UMBILICAL (1) TABLE COVER REINFORCED 44" X 78" L/F (2) WRAPPER 24" X 24" LI EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

FDA Enforcement
Class I ·Terminated·Customed, Inc·September 10, 2014

Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

FDA Enforcement
Class II ·Terminated·Bausch & Lomb Inc·December 31, 2014

Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles.

FDA Enforcement
Class II ·Terminated·Cardinal Health·April 3, 2013

HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE (1) SHEET DRAPE 41 " X 58" SMS (1) MAYO TRAY LARGE (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (1) DRAPE BARIATRIC (1) BLADE SURGICAL #10 STAINLESS STEEL (1) CUP SPECIMEN WITH CAP 4oz (1) BLADE SURGICAL #15 STAINLESS STEEL (30) LAP SPONGE PREWASH 18" X 18" XRD (1) STRIP STERI CLOSURE W X 4" (1) POLISHER CAUTERY TIP (1) NEEDLE ECLIPSE 22 X 1 Y2 (4) TOWEL ABSORBENT 15" X 20" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR (1) FORCE TRIVERSE (1) SYRINGE BULB 60CC (1) BLADE EXTENDED ELECT. 16.51cm (2) TUBE SUCTION CONNECT Y." X 12' (2) CHLORAPREP 26ML APPLICATOR TEAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Enforcement
Class I ·Terminated·Customed, Inc·September 10, 2014

Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

FDA Enforcement
Class I ·Completed·Ethicon Endo-Surgery Inc·May 22, 2019