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 PAIN TRAY, REF 89-10464.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Endo Pack, Item No.682-509
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Medical Vein, Item No.682-330
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal BASIC NEURO PACK, REF 89-7258.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, BREAST PACK, Item No.570-2397
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal CARDIAC LINEN PACK, REF 89-10543.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Power-PRO 2, Model No. 6507, Item No. 650705550001 (US)
FDA Device · Class II · 2022-12-21 · Stryker Medical Division - DeRoyal HAND PACK, REF 89-10314.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
FDA Device · Class II · 2022-12-21 · Zimmer - HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
FDA Device · Class II · 2022-12-21 · Stradis Medical - IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measure…
FDA Device · Class II · 2022-12-21 · Siemens Healthcare Diagnostics - GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Phleb, Item No.682-1425
FDA Device · Class II · 2022-12-21 · Stradis Medical - IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnosti…
FDA Device · Class II · 2022-12-21 · Siemens Healthcare Diagnostics - STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal VIT RD PACK 86ST, REF 89-7308.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, Knee Pack, Item No.570-2908
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - CarePoint 60 mL Syringe Without Needle, REF: 04-7560
FDA Device · Class II · 2022-12-21 · Allison Medical - DeRoyal LUMBAR DISC PACK, REF 89-10590.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, Basin Pack, Item No.570-1692
FDA Device · Class II · 2022-12-21 · Stradis Medical - Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, RHINO PACK, Item No.570-3070
FDA Device · Class II · 2022-12-21 · Stradis Medical - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal PACEMAKER ICD PACK, REF 89-10216.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal CRANI PACK, REF 89-10242.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SPINE PACK, REF 89-8361.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal BIOPSY PACK, REF 89-9270.04
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED CATARACT PACK, REF 89-5790.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal CUSTOM NEURO PACK, REF 89-8392.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal BASIC NEURO PACK, REF 89-7258.12
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal BASIC EYE PACK, REF 89-8337.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal SHOULDER PACK, REF 89-9449.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear…
FDA Device · Class II · 2022-12-21 · Siemens Medical Solutions Usa - DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SHOULDER PACK, REF 89-6830.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, OMFS, Item No.570-2779
FDA Device · Class II · 2022-12-21 · Stradis Medical - Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal GU ROBOTIC PACK, REF 89-7063.12
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal MYELOGRAM PACK, REF 89-9304.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal TOTAL HIP PACK, REF 89-9301.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
FDA Device · Class II · 2022-12-21 · Zimmer - GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal TLIF PACK, REF 89-8780.04
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal CATARACT PACK, REF 89-7135.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1
FDA Device · Class II · 2022-12-21 · Stradis Medical - www.StradisHealthcare.com, Endovenous Pack, Item No.682-494
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal BASIC NEURO PACK, REF 89-7523.15
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal MAJOR ORTHO PACK, REF 89-9250.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
FDA Device · Class II · 2022-12-21 · Stradis Medical - GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal PEDI ORTHO PACK, REF 89-5323.20
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard)
FDA Device · Class II · 2022-12-21 · Leica Microsystems - DeRoyal BASIC NEURO PACK, REF 89-7523.16
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal CATARACT PACK CSM, REF 89-6863
FDA Device · Class II · 2022-12-21 · Deroyal Industries - IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantita…
FDA Device · Class II · 2022-12-21 · Siemens Healthcare Diagnostics - HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091
FDA Device · Class II · 2022-12-21 · Stradis Medical
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)