Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: LS MS PACK
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: IM NAIL
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANS
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BA
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR CDS-LF k. PLASTIC BREAST CDS-LF l. BREAST-HERNIA-PORT CDS-LF m. DAY SURG PLASTIC CDS n. PLASTIC SURGERY PACK o. PLASTIC PACK-LF p. PLASTIC-GENERAL SURGERY PACK q. PLASTIC PACK-LF r. ABDOMINOPLASTY/BREAST s. PLAS
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k. LAP CHOLE CDS l. GENERAL LAPAROSCOPY CDS m. MINOR PROCEDURE CDS n. MAJOR CDS o. HERNIA CDS p. MINOR CDS q. MAJOR PROCEDURE CDS r. LAP GASTRIC BYPASS CDS UCC s. GENERAL LAPAROSCOPY CDS t. LAP CHOLE CDS u. CUH MAJOR PROC
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NEC
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS ACCESS PACK m. VASCULAR ACCESS PACK n. ARTERIOGRAM PACK o. AV FISTULA/GRAFT INSER PK p. VEIN ABLATION PACK q. PORT PACK r. MINOR VASCULAR s. FISTULA PACK t. AV FISTU
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OP
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIFEMORAL ARTERY PACK-LF. Sterile Procedural Tray
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIUNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IILOCAL PACK. Sterile Procedural Tray.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IITRACH PACK. Sterile Procedural Tray.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIANCILLARY PACK-LF. Sterile Procedural Tray.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- 2023-02-15FDA-DeviceOwens & Minor Distribution, Inc.Class IIIFLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
- 2023-02-15FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IGE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE,
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
- 2023-02-15FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IGE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
- 2023-02-15FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IGE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
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