FDA Device · 2022
FDA Device recalls in 2022
RecallRadar indexes 2,191 FDA Device recall notices published in 2022. By classification: 168 Class I, 1,946 Class II, 77 Class III.
- Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-RO…
FDA Device · Class II · 2022-10-05 · Cook - Coons Interventional Wire Guide, Guidewire
FDA Device · Class II · 2022-10-05 · Cook - MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS…
FDA Device · Class II · 2022-10-05 · Medline Industries Northfield - Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST…
FDA Device · Class II · 2022-10-05 · Cook - a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313. b. DYNAREX DynaCare WIPE, WET FLUSHABLE ADULT 9X13" (24/PK 2…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - NanoSight LM10 fitted with LM14 module
FDA Device · Class II · 2022-10-05 · Malvern Panalytical - MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Ca…
FDA Device · Class II · 2022-10-05 · Medline Industries Northfield - Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
FDA Device · Class II · 2022-10-05 · Barco Nv - Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5…
FDA Device · Class II · 2022-10-05 · Cook - Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
FDA Device · Class II · 2022-10-05 · Leica Microsystems - Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
FDA Device · Class II · 2022-10-05 · Cook - DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS…
FDA Device · Class II · 2022-10-05 · Medline Industries Northfield - Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364…
FDA Device · Class II · 2022-10-05 · Cook - VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits)
FDA Device · Class II · 2022-10-05 · Angiodynamics - a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSIN…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
FDA Device · Class II · 2022-10-05 · Leica Microsystems - Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY)
FDA Device · Class II · 2022-10-05 · Cook - TANDEM LIFE LivaNova LIFESPARC Controller
FDA Device · Class I · 2022-10-05 · Cardiac Assist - Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparos…
FDA Device · Class II · 2022-10-05 · Olympus - Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
FDA Device · Class II · 2022-10-05 · Cook - a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTI…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
FDA Device · Class II · 2022-10-05 · Coopersurgical - a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS ME…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - NanoSight LM10 fitted with LM12 module
FDA Device · Class II · 2022-10-05 · Malvern Panalytical - Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G0…
FDA Device · Class II · 2022-10-05 · Cook - IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US
FDA Device · Class II · 2022-10-05 · Siemens Healthcare Diagnostics - OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
FDA Device · Class II · 2022-10-05 · Ossur Americas - a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b.…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001
FDA Device · Class II · 2022-10-05 · Surgical Innovations - a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (2…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
FDA Device · Class II · 2022-10-05 · Cook - Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
FDA Device · Class II · 2022-10-05 · Leica Microsystems - a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SU…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
FDA Device · Class II · 2022-10-05 · Cook - Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTA…
FDA Device · Class II · 2022-10-05 · Collagen Matrix - VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx
FDA Device · Class II · 2022-10-05 · Biomerieux - a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Et…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
FDA Device · Class II · 2022-10-05 · Leica Microsystems - a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Ace…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 .…
FDA Device · Class II · 2022-10-05 · Carefusion 303 - Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
FDA Device · Class II · 2022-10-05 · Cook - Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
FDA Device · Class II · 2022-10-05 · Sunmed Holdings - Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-…
FDA Device · Class II · 2022-10-05 · Cook - MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Device · Class II · 2022-10-05 · Micro X - The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg,…
FDA Device · Class II · 2022-09-28 · Randox Laboratories - Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
FDA Device · Class II · 2022-09-28 · Associates - BD MaxGuard Extension Set, REF: ME1069
FDA Device · Class II · 2022-09-28 · Carefusion - BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
FDA Device · Class II · 2022-09-28 · Carefusion - BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
FDA Device · Class II · 2022-09-28 · Carefusion - Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
FDA Device · Class II · 2022-09-28 · Paragon 28 - BEQ-HLS 7050 USA
FDA Device · Class II · 2022-09-28 · Maquet Medical Systems Usa - BEQ-HLS 5050 USA
FDA Device · Class II · 2022-09-28 · Maquet Medical Systems Usa - BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
FDA Device · Class II · 2022-09-28 · Carefusion - Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue…
FDA Device · Class II · 2022-09-28 · Diversatek Healthcare - BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
FDA Device · Class II · 2022-09-28 · Carefusion - BEQ-HLS 7050 USA
FDA Device · Class II · 2022-09-28 · Maquet Medical Systems Usa - ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
FDA Device · Class II · 2022-09-28 · Gelita Medical - AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems
FDA Device · Class II · 2022-09-28 · Fresenius Medical Care Holdings - BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
FDA Device · Class II · 2022-09-28 · Carefusion - PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
FDA Device · Class II · 2022-09-28 · Ethicon - BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
FDA Device · Class II · 2022-09-28 · Carefusion - BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
FDA Device · Class II · 2022-09-28 · Carefusion - BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
FDA Device · Class II · 2022-09-28 · Carefusion - Puritan Bennett 560 Ventilator, PB560, CFN 4096600
FDA Device · Class II · 2022-09-28 · Covidien - BEQ-HLS 5050 USA
FDA Device · Class II · 2022-09-28 · Maquet Medical Systems Usa - AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems
FDA Device · Class II · 2022-09-28 · Fresenius Medical Care Holdings - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175
FDA Device · Class II · 2022-09-21 · Cook - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151
FDA Device · Class II · 2022-09-21 · Cook - SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Device · Class II · 2022-09-21 · Fujifilm Healthcare Americas - Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System
FDA Device · Class II · 2022-09-21 · Mako Surgical - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161
FDA Device · Class II · 2022-09-21 · Cook - 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer
FDA Device · Class II · 2022-09-21 · Icu Medical - Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516
FDA Device · Class II · 2022-09-21 · Cook - Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937
FDA Device · Class II · 2022-09-21 · Cook - 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock
FDA Device · Class II · 2022-09-21 · Icu Medical - FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 3…
FDA Device · Class II · 2022-09-21 · Carwild - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149
FDA Device · Class II · 2022-09-21 · Cook - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176
FDA Device · Class II · 2022-09-21 · Cook - MicroClave Clear Neutral Connector
FDA Device · Class II · 2022-09-21 · Icu Medical - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172
FDA Device · Class II · 2022-09-21 · Cook - Surpria 64: Software Version V3.11, V3.22
FDA Device · Class II · 2022-09-21 · Fujifilm Healthcare Americas - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173
FDA Device · Class II · 2022-09-21 · Cook - Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intend…
FDA Device · Class II · 2022-09-21 · Isopure - 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set
FDA Device · Class II · 2022-09-21 · Icu Medical - 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer
FDA Device · Class II · 2022-09-21 · Icu Medical - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608
FDA Device · Class II · 2022-09-21 · Cook - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - BIOPHEN UFH Control Plasma
FDA Device · Class III · 2022-09-21 · Aniara Diagnostica - PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Device · Class III · 2022-09-21 · Polymer Technology Systems - MicroClave Clear Neutral Connector
FDA Device · Class II · 2022-09-21 · Icu Medical - Verify SixCess Challenge Pack
FDA Device · Class III · 2022-09-21 · Steris Hopkins Facility - INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing…
FDA Device · Class II · 2022-09-21 · Mallinckrodt - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152
FDA Device · Class II · 2022-09-21 · Cook
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)