141 results
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14ms
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Sources: EU EUDAMED, US FDA
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-10013-159, SIZE 1-RIGHT MED, 9MM; f) REF 1-10013-160, SIZE 1-RIGHT MED, 10MM; g) REF 1-10013-161, SIZE 1-RIGHT MED, 11MM; h) REF 1-10013-163, SIZE 1-RIGHT MED, 13MM; i) REF 1-10013-209, SIZE 2-LEFT MED, 9MM; j) REF 1-10013-210, SIZE 2-LEFT MED, 10MM; k) REF 1-10013-211, SIZE 2-LEFT MED, 11MM; l) REF 1-10013-213, SIZE 2-LEFT MED, 13MM; m) REF 1-10013-259, SIZE 2-RIGHT MED, 9MM; n) REF 1-10013-260, SIZE 2-RIGHT MED, 10MM; o) REF 1-10013-261, SIZE 2-RIGHT MED, 11MM; p) REF 1-10013-263, SIZE 2-RIGHT MED, 13MM; q) REF 1-10013-309, SIZE 3-LEFT MED, 9MM; r) REF 1-10013-310, SIZE 3-LEFT MED, 10MM; s) REF 1-10013-311, SIZE 3-LEFT MED, 11MM; t) REF 1-10013-313, SIZE 3-LEFT MED, 13MM; u) REF 1-10013-359, SIZE 3-RIGHT MED, 9MM; v) REF 1-10013-360, SIZE 3-RIGHT MED, 10MM; w) REF 1-10013-361, SIZE 3-RIGHT MED, 11MM; x) REF 1-10013-363, SIZE 3-RIGHT MED, 13MM; y) REF 1-10013-409, SIZE 4-LEFT MED, 9MM; z) REF 1-10013-410, SIZE 4-LEFT MED, 10MM; aa) REF 1-10013-411, SIZE 4-LEFT MED, 11MM; bb) REF 1-10013-413, SIZE 4-LEFT MED, 13MM; cc) REF 1-10013-459, SIZE 4-RIGHT MED, 9MM; dd) REF 1-10013-460, SIZE 4-RIGHT MED, 10MM; ee) REF 1-10013-461, SIZE 4-RIGHT MED, 11MM; ff) REF 1-10013-463, SIZE 4-RIGHT MED, 13MM; gg) REF 1-10013-509, SIZE 5-LEFT MED, 9MM; hh) REF 1-10013-510, SIZE 5-LEFT MED, 10MM; ii) REF 1-10013-511, SIZE 5-LEFT MED, 11MM; jj) REF 1-10013-513, SIZE 5-LEFT MED, 13MM; kk) REF 1-10013-559, SIZE 5-RIGHT MED, 9MM; ll) REF 1-10013-560, SIZE 5-RIGHT MED, 10MM; mm) REF 1-10013-561, SIZE 5-RIGHT MED, 11MM; nn) REF 1-10013-563, SIZE 5-RIGHT MED, 13MM; oo) REF 1-10013-609, SIZE 6-LEFT MED, 9MM; pp) REF 1-10013-610, SIZE 6-LEFT MED, 10MM; qq) REF 1-10013-611, SIZE 6-LEFT MED, 11MM; rr) REF 1-10013-613, SIZE 6-LEFT MED, 13MM; ss) REF 1-10013-659, SIZE 6-RIGHT MED, 9MM; tt) REF 1-10013-660, SIZE 6-RIGHT MED, 10MM; uu) REF 1-10013-661, SIZE 6-RIGHT MED, 11MM; vv) REF 1-10013-663, SIZE 6-RIGHT MED, 13MM; Unicondylar knee prothesis
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code HSX·May 2, 2023
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC
FDA Recall
Open, Classified
·Product code BYG·November 21, 2025
CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DKST BRIT P/C; (7) Part #2092930-003, DSP LCD 22IN MED W/TCH W/DKST EURO P/C; (8) Part #2092930-004, DSP LCD 22IN MED W/TCH W/DKST ITA P/C; (9), Part #2092930-005, DSP LCD 22IN MED W/TCH W/DKST INDIAN P/C; (10) Part #2092930-006, DSP LCD 22IN MED W/TCH W/DKST ISREAL P/C; (11) Part #2092930-007, DSP LCD 22IN MED W/TCH W/DKST SWISS P/C; (12) Part #2092930-008, DSP LCD 22IN MED W/TCH W/DKST AUSTRL P/C; (13) Part #2092930-009, DSP LCD 22IN MED W/TCH W/DKST JPN; (14) Part #2092930-010, DSP LCD 22IN MED W/TCH W/DKST BRZL P/C; (15) Part #2092930-011, DSP LCD 22IN MED W/TCH W DKST ARGNT P C; (16) Part #2092930-012, DSP LCD 22IN MED W TCH W DKST DENMARK; (17) Part #2092930-013, DSP LCD22IN MED W TCH W DKST S AFRICA P C; and (18) Part #2092930-014, DSP LCD22IN MED W TCH W DKST CHINA P C.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code DXJ·May 10, 2022
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel
FDA Recall
Open, Classified
·Mac Medical Supply Co Inc·Product code ITX·August 4, 2021
Med-Riser MR600 Patient Lift
FDA Recall
Open, Classified
·Med-Mizer, Inc.·Product code FSA·February 3, 2023
Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile; (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile; (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile; (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile; (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile; (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile; (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile; (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile; (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile; (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile; (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile; (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FDE·August 16, 2023
Sit to Stand STS500 Patient Lift
FDA Recall
Open, Classified
·Med-Mizer, Inc.·Product code FSA·February 3, 2023
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
FDA Recall
Open, Classified
·Accelerated Care Plus Corporation·Product code ITX·August 25, 2021
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·April 5, 2023
Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017 B-M - SHUNT 22017 B-M ASSY US PER 90CM SM MED 22017B-LL - SHUNT 22017B-LL ASSY US PER 90CM SM LL 23093 - VALVE 23093 CONT. REG. LOW-LOW 27102 - VALVE 27102 CONTOURED SML LOW LOW 27553 M - VALVE 27553 M CSF-FLOW CNTRL SM EXTR MP 27643M - SHUNT 27643M ASSY SM PCATH130CM MED 27683M - SHUNT 27683M RG SNP PCATH90 PLI STD OE 42312 - VALVE 42312 SM CONTOURED LOW PRES IMP 42314- VALVE 42314 SM CONTOURED MED PRESS IMP 42316 - VALVE 42316 SM CONTOURED HIGH PRESS 42322 - VALVE 42322 CONTOURED REG LOW PRESS IMP 42324 - VALVE 42324 CONTOURED REG MED PRESS IMP 42326 - VALVE 42326 CONT HIGH PRESS IMP 42410 - VALVE 42410 ULTRA SMALL LOW-LOW 42414 - VALVE 42414 ULTRA SMALL MEDIUM PRESS IMP 42532 - VALVE 42532 BURR HOLE 12MM LOW PRESS IMP 42534 - VALVE 42534 BURR HOLE 12MM MED PRESS IMP 42536 - VALVE 42536 BURR HOLE 12MM HI PRESS IMP 42542 - VALVE 42542 BURR HOLE 16 MM LOW IMP 42544 - VALVE 42544 BURR HOLE 16MM MED PRESS IMP 42546 - VALVE 42546 BURR HOLE 16MM HI PRESS IMP 46564 - SHUNT 46564 CSF SNAP ASSY US MEDIUM 46622 - SHUNT 46622 CSF ASSY SMALL LOW CONT C/P 46624 - SHUNT 46624 CSF ASSY SMALL MED CONT C/P 46626 - SHUNT 46626 CSF ASSY SMALL HIGH CONT C/P 46642 - SHUNT 46642 ASSY REG LOW C/P-90CM 46644 - SHUNT 46644 ASSY REG MED C/P-90CM 46646 - SHUNT 46646 ASSY REG HIGH C/P-90CM 9003 A - KIT 9003 A INTL ONLY SHUNT CONT SM LO 9003 B - KIT 9003 B INTL ONLY SHUNT CONT SM ME 9003 C - KIT 9003 C INTL ONLY SHUNT CONT SM HI 9003 D - KIT 9003 D SHUNT INTL ONLY CONT REG L 9003 E - KIT 9003 E SHUNT INTL ONLY CONT REG M 9003 F - KIT 9003 F SHUNT INTL ONLY CONT REG H 9040 A - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 9040 B - KIT 9040 B SHUNT INTL ONLY BH 12MM MED 9040 C - KIT 9040 C SHUNT INTL ONLY BH 12MM HIGH 9040 D - KIT 9040 DSHUNT INTL ONLY BH 16MM LOW 9040 E - KIT 9040 E SHUNT INTL ONLY BH 16MM MED 9040 F - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 92322 - VALVE 92322 CSF CONT REG LOW BIO 92324 - VALVE 92324 CSF CONT REG MED BIO
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code JXG·January 11, 2021
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill; (6) K616-015 75V - Class A Office - 3-Shelf Cabinet; (7) K618-016 EMT - Duke Energy TD - Red Bag; (8) KR618-016 EMTR - Duke Energy TD - Refill; (9) K616-008 FAC-3 - Class B + Meds - 3 Shelf Cabinet; (10) KR616-008 FAC-3R - Class B + Meds - Refill; (11) K618-013 FAC-3 - Five Star Safety - w/Logo; (12) K611-044 FAC-3 - Uline 100 person - w/Logo; (13) K620-609 FAC-3 - Uline Class B + Meds - w/Logo; (14) K616-072 FAC-4 - Choate Construction - w/Logo; (15) KR616-072 FAC-4R - Choate Construction - Refill; (16) K616-066 FAC-4 - Class B + Meds - 4 Shelf Cabinet; (17) KR616-066 FAC-4R - Class B + Meds - Refill; (18) K612-159 FAC-4 - Uline - w/Logo - w/Contents sticker; (19) K616-067 FAC-5 - Class B - 5 Shelf Cabinet; (20 KR616-067 FAC-5R - Class B - Refill
FDA Recall
Open, Classified
·Certified Safety Mfg Inc·Product code LRR·April 5, 2022
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
FDA Recall
Open, Classified
·North Coast Medical Inc·Product code ITX·August 27, 2021
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
FDA Recall
Open, Classified
·DJO, LLC·Product code ITX·September 7, 2021
MED-810A Zemits NDPrime Laser products
FDA Recall
Open, Classified
·Advance-Esthetic LLC·Product code GEX·October 9, 2023
GEO-MED BIOPSY TRAY, REF 89-8753.01
FDA Recall
Open, Classified
·DeRoyal Industries Inc·Product code LRO·November 3, 2022
EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
FDA Recall
Open, Classified
·Covidien LLC·Product code GDW·May 17, 2019
GEO-MED CATARACT PACK, REF 89-5790.08
FDA Recall
Open, Classified
·DeRoyal Industries Inc·Product code LRO·November 3, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
FDA Recall
Open, Classified
·DeRoyal Industries Inc·Product code LRO·November 3, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
FDA Recall
Open, Classified
·DeRoyal Industries Inc·Product code LRO·November 3, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
FDA Recall
Open, Classified
·DeRoyal Industries Inc·Product code LRO·November 3, 2022