126 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PACK-LF, Pack Number DYNJ0046667A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OKV·February 11, 2025
Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL ABSORBENT 15 X 20 LIF (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF (1) SYRINGE EAR/ULCER 2oz. LIF (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF (2) LEGGINS W/7'' CUFF 30X42 L/F (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) OB PAD WRAP OVERNIGHT (1) TABLE COVER REINFORCED 50X90 LIF (1) DRAPE UNDERBUTTOCK W/POUCH 44X35" (1) CLAMP UMBILICAL CORD LIF (1) BOWL PLASTIC 80oz. LIF (1) LID FOR BOWL 80oz. CLEAR LIF (1) BEANNIES BABY (5) LAP SPONGE PREWASH 18X18XRD (1) MAYO TRAY SMALL (1) DRAPE SHEET 41X58 SMS LIF (1) UNDERPAD 36X36 BEIGE (1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON (10) GAUZE SPONGE 4X4 16PLY LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OKV·May 20, 2014
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.
FDA Recall
Open, Classified
·Product code OKV·March 19, 2026
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.
FDA Recall
Terminated
·EHOB, Inc.·Product code IKY·January 19, 2020
Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable.
FDA Recall
Terminated
·EHOB, Inc.·Product code FMP·June 9, 2020
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
FDA Recall
Open, Classified
·EHOB, Inc.·Product code IKY·April 19, 2021
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FDX·December 28, 2021
Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FGE·July 29, 2022
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code GAA·July 29, 2022
Freeman Pancreatic Flexi-Stent Catalog Number: 6535
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FGE·July 29, 2022
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FBK·October 4, 2024
Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FGE·July 29, 2022
Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code OCZ·July 29, 2022
Hobbs Medical Grasping Forceps Catalog Number:5004
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code OCZ·July 29, 2022
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FAD·July 29, 2022
Freeman Pancreatic Flexi-Stent Catalog Number: 6567
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FGE·July 29, 2022
Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code EYB·July 29, 2022
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code GAA·July 29, 2022
Hobbs Medical Polypectomy Snare, Catalog No. 7202
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code OCZ·June 3, 2022
Freeman Pancreatic Flexi-Stent Catalog Number: 6544
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FGE·July 29, 2022