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.
- DeRoyal KIT HEART B PACK, REF 89-9042.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal BASIC EYE PACK, REF 89-8337.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, Labiaplasty PackItem No.570-3118
FDA Device · Class II · 2022-12-21 · Stradis Medical - Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-…
FDA Device · Class I · 2022-12-21 · Arrow International - STRADIS HEALTHCARE, Angioplasty, Item No.682-1937
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal BIOPSY PACK, REF 89-9270.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, GYN PACK, Item No.570-2625
FDA Device · Class II · 2022-12-21 · Stradis Medical - Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
FDA Device · Class II · 2022-12-21 · Conmed - DeRoyal PODIATRY PACK, REF 89-8359.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal FOOT PACK, REF 89-9252.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Breast, Item No.693-276
FDA Device · Class II · 2022-12-21 · Stradis Medical - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal KIT TOTAL HIP, REF 89-8861.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal TRANS CANAL PACK, REF 89-7157.12
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal NEURO PACK, REF 89-9253.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, CATH PACK Item No.570-2789
FDA Device · Class II · 2022-12-21 · Stradis Medical - BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal ACDF PACK, REF 89-8779.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal MYELOGRAM PACK, REF 89-9304.06
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal PODIATRY PACK, REF 89-8359.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal CRANI PACK, REF 89-10242.04
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal LUMBAR FUSION PACK, REF 89-10211.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, Vas Pack, Item No.888-2520
FDA Device · Class II · 2022-12-21 · Stradis Medical - NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
FDA Device · Class II · 2022-12-21 · Zimmer - DeRoyal SPINAL FUSION PACK, REF 89-7515.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal BIOPSY PACK, REF 89-9739.06
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SHOULDER PACK, REF 89-9449.12
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal CRANI PACK, REF 89-10202.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Cordis Angiographic Catheter Extensions
FDA Device · Class II · 2022-12-21 · Cordis Us - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal NEURO PACK, REF 89-10682.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal LAPINECTOMY PACK, REF 89-7198.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal BIOPSY PACKPACK, REF 89-9756.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
FDA Device · Class II · 2022-12-21 · Stradis Medical - BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species
FDA Device · Class II · 2022-12-21 · Becton Dickinson And - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal FOOT PACK, REF 89-9252.06
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal BASIC PACK, REF 89-8633.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
FDA Device · Class II · 2022-12-21 · Leica Microsystems - HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal KIT HEART B PACK, REF 89-9042.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal BREAST TRAY, REF 89-7033.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, Basin Set, Item No.570-1803
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal SPINE PACK, REF 89-8361.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal CATARACT PACK, REF 89-8650.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal NEURO PACK, REF 89-10171.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal LUMBAR DISC PACK, REF 89-10605.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal NEURO PACK, REF 89-10171.06
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal NEURO PACK, REF 89-9253.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal LAPINECTOMY PACK, REF 89-7198.11
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SHOULDER KIT, REF 89-9497.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
FDA Device · Class II · 2022-12-21 · Stradis Medical - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
FDA Device · Class II · 2022-12-21 · Zimmer - STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal CATARACT PACK, REF 89-10040.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal GU PACK, REF 89-10665.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SPINAL FUSION PACK, REF 89-7515.12
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal CATARACT PACK, REF 89-10086.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Vein, Item No.682-577
FDA Device · Class II · 2022-12-21 · Stradis Medical - GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal EYE TRAY PGYBK, REF 89-7978.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SPINAL FUSION PACK, REF 89-7515.14
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal TOTAL HIP KIT, REF 89-9498.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Angio Pack, Item No.686-199
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - NUVASIVE MAGEC MAGEC 2 Rod
FDA Device · Class II · 2022-12-21 · Nuvasive Specialized Orthopedics
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)