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    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-27018); g) D 2.7MM X 20MM (002-E-27020); h) D 2.7MM X 22MM (002-E-27022); i) D 2.7MM X 24MM (002-E-27024); j) D 2.7MM X 26MM (002-E-27026); k) D 2.7MM X 28MM (002-E-27028); l) D 2.7MM X 30MM (002-E-27030); m) D 2.7MM X 32MM (002-E-27032); n) D 2.7MM X 34MM (002-E-27034); o) D 2.7MM X 36MM (002-E-27036); p) D 2.7MM X 38MM (002-E-27038); q) D 2.7MM X 40MM (002-E-27040)

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·June 13, 2018

    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·September 8, 2021

    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-E-32022) h) D 3.2MM X 24MM (002-E-32024) i) D 3.2MM X 26MM (002-E-32026) j) D 3.2MM X 28MM (002-E-32028) k) D 3.2MM X 30MM (002-E-32030) l) D 3.2MM X 32MM (002-E-32032) m) D 3.2MM X 34MM (002-E-32034) n) D 3.2MM X 36MM (002-E-32036) o) D 3.2MM X 38MM (002-E-32038) p) D 3.2MM X 40MM (002-E-32040) q) D 3.2MM X 42MM (002-E-32042) r) D 3.2MM X 44MM (002-E-32044) s) D 3.2MM X 46MM (002-E-32046) t) D 3.2MM X 48MM (002-E-32048) u) D 3.2MM X 50MM (002-E-32050)

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·June 13, 2018

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

    Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7MM X 12MM (002-D-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016); f) D 2.7MM X 18MM (002-D-27018); g) D 2.7MM X 20MM (002-D-27020); h) D 2.7MM X 22MM (002-D-27022); i) D 2.7MM X 24MM (002-D-27024); j) D 2.7MM X 26MM (002-D-27026); k) D 2.7MM X 28MM (002-D-27028); l) D 2.7MM X 30MM (002-D-27030); m) D 2.7MM X 32MM (002-D-27032); n) D 2.7MM X 34MM (002-D-27034); o) D 2.7MM X 36MM (002-D-27036); p) D 2.7MM X 38MM (002-D-27038); q) D 2.7MM X 40MM (002-D-27040)

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·June 13, 2018

    EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) NEEDLE HYPODERMIC 1 80 X I Y, ( I) WASI-l BASIN ROUND 6QT (I) INSTRUMENT POUCH 7 X I I 2 COMPART (I) STRIP STER I CLOSURE W' X 4" LIF (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF ( I) SH EET ENT SPLIT 11 0 X 77 (2) LITE GLOVE (2) NEEDLE H YPODERM IC 27G X I \!..'' (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF (4) COTrON APPLICATOR 6" WOOD ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED LIF ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF ( I ) TRAY MAYO SMALL ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF ( I ) DRAPE MICROSCOPE ZEI SS ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF ( I ) TIME OUT BEACON NON WOV EN ST LIF ( I ) BLADE M INUATURE CARBON STEEL ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, (2) SCALPEL SAFETY WEIGHTED # 1 5 ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF ( I ) WRAPPER 24" X 24" WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" ( I ) TRAY 3/COMPARTM ENT ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE (3) TI P ABSORBENT APPLICATOR STICK SPONGE (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF (2) GLOVE MED FREETOUCI-1 VYN I L P/F (2) COTrON APPLICATOR 6" WOOD 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

    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34MM (002-D-32034) n) D 3.2MM X 36MM (002-D-32036) o) D 3.2MM X 38MM (002-D-32038) p) D 3.2MM X 40MM (002-D-32040) q) D 3.2MM X 42MM (002-D-32042) r) D 3.2MM X 44MM (002-D-32044) s) D 3.2MM X 46MM (002-D-32046) t) D 3.2MM X 48MM (002-D-32048) u) D 3.2MM X 50MM (002-D-32050)

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·June 13, 2018

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    FDA Enforcement
    Class II ·Terminated·Bard Medical Division·May 8, 2019

    Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 25, 2019

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·November 14, 2018

    Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE DSE TRACH; e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); f. HALYARD* 14FR TRACH CARE DSE ENDO; g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); h. HALYARD* 14FR TRACH CARE DSE TRACH; i. HALYARD* 14FR DSE 12IN/30.5CM; j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH; k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO; l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO; m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO; n. HALYARD* 14FR TRACH CARE DSE MDI ENDO; o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO; q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE); r. HALYARD* 16FR TRACH CARE DSE ENDO; s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·July 22, 2021

    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·October 31, 2018

    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314 f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410 i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412 j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412 k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414 l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414 m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510 n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510 o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512 p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512 q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514 r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514 s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610 t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610 u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612 v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612 w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614 x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·March 29, 2017

    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82, REF 413439, q) AST-N261, REF 413753, r) AST-XN06, REF 413944, s) AST-N275, REF 414313, t) AST-GP75, REF 415670, u) AST-N300, REF 416241, v) AST-N308, REF 413913, w) AST-N314, REF 417027, x) AST-N318, REF 417952, y) AST-P643, REF 418671, z) AST-YS08, REF 420739, aa) AST-N348, REF 420856, bb) AST-ST02, REF 420915, cc) AST-ST03, REF 421040, dd) AST-N355, REF 421351, ee) AST-P654, REF 421912, ff) AST-P655, REF 421913, gg) AST-N371, REF 422024, hh) AST-N372, REF 422241, ii) AST-N379, REF 423052,

    FDA Enforcement
    Class II ·Terminated·Organon Teknika Inc·March 6, 2019

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

    Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model number DS200H; d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS; e) REMStar Plus M w/Smartcard, US model number DS200S; and f) REMStar Plus w/C Flex Dom model number 1009586. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

    Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower) Ultrafine Qty 1 model number 1036915, b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS; c) REMStar Auto M. w/Smartcard A FLEX US model number DS510S; d) REMStar Auto M. w/Smartcard, CNDA model number CA501S; e) REMStar Auto M w/Smartcard Intl model number IN501S; f) REMStar Auto M w/Smartcard US model number DS500S; g) REMStar Auto w/C-FLEX CANADA model number CA1017454; and h) REMStar Auto w/C-FLEX Domestic Core Pkg model number 1017476. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007