33 results · 20ms · Sources: EU EUDAMED, US FDA

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3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.

FDA Recall
Terminated ·3M Company Health Care Business 3m Center·Product code FLF·January 22, 2016

Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PACK, REF DYNJ42884; h) RFT D & C PACK, REF DYNJ50851; i) KIT OB, REF DYNJ906623; j) D AND C, REF DYNJ907957A; k) CHS OB PACK III, REF DYNJCH907

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OKV·September 4, 2024

Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations

FDA Recall
Terminated ·Pentax Medical Company·Product code EOB·April 6, 2016

11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code EOB·April 1, 2022

Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.

FDA Recall
Terminated ·Vision-Sciences, Inc.·Product code EOB·December 27, 2011

ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

FDA Recall
Terminated ·Olympus Corporation of the Americas·Product code EOB·May 5, 2020

Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.

FDA Recall
Terminated ·Vision-Sciences, Inc.·Product code EOB·December 27, 2011

InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K45BTOL LCS1545TPOL LCS1845TPST LCS4K45TPOL LCS1570BTOL LCS1870BTST LCS4K70BTOL LCS1570TPOL LCS1870TPST LCS4K70TPOL

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code EOB·January 16, 2024

Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE

FDA Recall
Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code EOB·December 4, 2023

InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code EOB·April 3, 2024

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

ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

FDA Recall
Open, Classified ·Erbe Medical, LLC·Product code OCX·March 31, 2026

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

FDA Recall
Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

FDA Recall
Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208

FDA Recall
Open, Classified ·Erbe Medical, LLC·Product code FEQ·March 31, 2026

ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

FDA Recall
Open, Classified ·Erbe Medical, LLC·Product code OCX·March 31, 2026

Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

FDA Recall
Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

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