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.
- Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Polypectomy Snare Catalog Number: 7202
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Posi-Stop Injection Needle Catalog Number: 4722
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Grasping Forceps Catalog Number: 5008
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Posi-Stop Injection Needle Catalog Number: 4718
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Prismaflex M Set: M150 (product code 109990)
FDA Device · Class II · 2022-10-19 · Baxter Healthcare - Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6567
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Prismaflex M Set: M60 (product code 106696), M100 (product code 106697)
FDA Device · Class II · 2022-10-19 · Baxter Healthcare - Hobbs Posi-Stop Injection Needle Catalog Number: 4702
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Posi-Stop Injection Needle Catalog Number: 4704
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6568
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Grasping Forceps Catalog Number:5004
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6562
FDA Device · Class II · 2022-10-19 · Hobbs Medical - COVID Test Kit Nonsterile
FDA Device · Class II · 2022-10-19 · American Contract Systems - Hobbs Posi-Stop Injection Needle Catalog Number: 4712
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Cytology Brush Catalog Number: 4206
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
FDA Device · Class II · 2022-10-19 · Steris - Hobbs Medical Polypectomy Snare Catalog Number: 4563
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Helical Retrieval Basket Catalog Number: 4816
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6535
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Posi-Stop Injection Needle Catalog Number: 4720
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Helical Retrieval Basket Catalog Number: 4806
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Helical Retrieval Basket Catalog Number: 4824
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6544
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Helical Retrieval Basket Catalog Number: 4814
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142)
FDA Device · Class II · 2022-10-19 · Baxter Healthcare - Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Veritas Advanced Infusion Packs
FDA Device · Class II · 2022-10-19 · Johnson And Johnson Surgical Vision - Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Prismaflex HF20 Set (product code 109841)
FDA Device · Class II · 2022-10-19 · Baxter Healthcare - Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640)
FDA Device · Class II · 2022-10-19 · Baxter Healthcare - Hobbs Helical Retrieval Basket Catalog Number: 4808
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Helical Retrieval Basket Catalog Number: 4832
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Medical Cytology Brush Catalog Number: 4204
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
FDA Device · Class II · 2022-10-19 · Luminostics - Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Jiangsu Well Biotech Co.,Ltd
FDA Device · Class I · 2022-10-19 · Jiangsu Well Biotech - Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Helical Retrieval Basket Catalog Number: 4830
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6584
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Philips Respironics DreamWear Full Face Mask
FDA Device · Class I · 2022-10-12 · Philips Respironics - Therapy Mask 3100 NC/SP
FDA Device · Class I · 2022-10-12 · Philips Respironics - Wisp and Wisp Youth Nasal Mask
FDA Device · Class I · 2022-10-12 · Philips Respironics - Philips Respironics Amara View Minimal Contact Full-Face Mask
FDA Device · Class I · 2022-10-12 · Philips Respironics - G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
FDA Device · Class II · 2022-10-12 · Zimmer - stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set co…
FDA Device · Class II · 2022-10-12 · Wright Medical Technology - The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in…
FDA Device · Class II · 2022-10-12 · In My Bathroom - Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02
FDA Device · Class II · 2022-10-12 · B Braun Medical - DreamWisp Nasal Mask with Over the Nose Cushion
FDA Device · Class I · 2022-10-12 · Philips Respironics - The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site
FDA Device · Class II · 2022-10-12 · Hologic - stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set c…
FDA Device · Class II · 2022-10-12 · Wright Medical Technology - Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
FDA Device · Class II · 2022-10-12 · Synthes Usa Products - MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162
FDA Device · Class II · 2022-10-12 · Philips North America - Ivenix Infusion System (IIS), LVP Software
FDA Device · Class I · 2022-10-12 · Fresenius Kabi Usa - Ambra PACS, Ambra ProViewer
FDA Device · Class II · 2022-10-05 · Dicom Grid - Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire
FDA Device · Class II · 2022-10-05 · Cook - Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparos…
FDA Device · Class II · 2022-10-05 · Olympus - t:slim X2 insulin pump
FDA Device · Class II · 2022-10-05 · Tandem Diabetes Care - MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Bentson Wire Guide, Guidewire (OUS ONLY)
FDA Device · Class II · 2022-10-05 · Cook - t:slim X2 insulin pump
FDA Device · Class II · 2022-10-05 · Tandem Diabetes Care - Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparos…
FDA Device · Class II · 2022-10-05 · Olympus - Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
FDA Device · Class II · 2022-10-05 · Cook - Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
FDA Device · Class II · 2022-10-05 · Cook - Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
FDA Device · Class II · 2022-10-05 · Cook - Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02
FDA Device · Class II · 2022-10-05 · Howmedica Osteonics - a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate
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 I Benchtop Incubator (AY102295)
FDA Device · Class II · 2022-10-05 · Coopersurgical - a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) D…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire
FDA Device · Class II · 2022-10-05 · Cook - 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
FDA Device · Class II · 2022-10-05 · Cook - SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
FDA Device · Class II · 2022-10-05 · Cook - Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824
FDA Device · Class II · 2022-10-05 · Unomedical A S - Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G0045…
FDA Device · Class II · 2022-10-05 · Cook - Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01…
FDA Device · Class II · 2022-10-05 · Cook - Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503
FDA Device · Class II · 2022-10-05 · Surgical Innovations - Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 1…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENC…
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
FDA Device · Class III · 2022-10-05 · Mckesson Medical Surgical Corporate Office - Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
FDA Device · Class II · 2022-10-05 · Siemens Healthcare Diagnostics - Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire
FDA Device · Class II · 2022-10-05 · Cook - Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products)
FDA Device · Class III · 2022-10-05 · Baxter Healthcare
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)