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 NEURO SPINE BACK PACK PGYBK, REF 89-10853.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal EYE PACK, REF 89-8756.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal RETINAL PACK, REF 89-7336.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Surgery PK, Item No.682-1728
FDA Device · Class II · 2022-12-21 · Stradis Medical - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - STRADIS HEALTHCARE, Lipo, Item No.681-254
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
FDA Device · Class II · 2022-12-21 · Stradis Medical - GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal FOOT PACK, REF 89-9252.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal CNRV SPINAL PACK, REF 89-10532.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal CATARACT PACK, REF 89-8859.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal HAND PACK, REF 89-10314.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
FDA Device · Class II · 2022-12-21 · Zimmer - DeRoyal LAMI/CRANI PACK, REF 89-10787.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal HEART PACK, REF 89-8351.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, ENT PACK, Item No.570-2718
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal CANNULTED HIP PACK, REF 89-6977.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - HENRY SCHEIN, VEIN TRAY, Item No.570-2738
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal ENDOVENOUS PACK, REF 89-7762.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal HEART PACK, REF 89-8351.12
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal BASIC EYE PACK, REF 89-9233.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Ablation Pack, Item No.682-130
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal PORT PACK PGYBK, REF 89-8748.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal TOTAL HIP PACK, REF 89-9113.06
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Medical Action Industries Inc
FDA Device · Class II · 2022-12-14 · Medical Action Industries 306 - Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel - Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5073
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Small Joint OATS Set, REF AR-8981-06S, 6mm
FDA Device · Class II · 2022-12-14 · Arthrex - CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH 7-1/2" (190MM) , REF F-1000
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
FDA Device · Class I · 2022-12-14 · Caire - CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5067
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 In…
FDA Device · Class II · 2022-12-14 · Cardinal Health - Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
FDA Device · Class II · 2022-12-14 · Philips North America - The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacteria…
FDA Device · Class II · 2022-12-14 · Qvella - LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated
FDA Device · Class II · 2022-12-14 · Integrity Implants - CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5010
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
FDA Device · Class II · 2022-12-14 · Full Vision - IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantita…
FDA Device · Class II · 2022-12-14 · Siemens Healthcare Diagnostics - FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928
FDA Device · Class II · 2022-12-14 · Full Vision - HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
FDA Device · Class II · 2022-12-14 · Olympus - Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1303
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel - NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a…
FDA Device · Class II · 2022-12-14 · Medacta Usa - FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINA
FDA Device · Class II · 2022-12-14 · Full Vision - FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926
FDA Device · Class II · 2022-12-14 · Full Vision - CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
FDA Device · Class I · 2022-12-14 · Caire - Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel - CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED, OVERALL LENGTH 7-3/4" (195MM), REF F-1003
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
FDA Device · Class II · 2022-12-14 · Randox Laboratories - IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
FDA Device · Class II · 2022-12-14 · Randox Laboratories - Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bla…
FDA Device · Class II · 2022-12-14 · Cardinal Health - CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
FDA Device · Class II · 2022-12-14 · Philips North America - Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1030
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated
FDA Device · Class II · 2022-12-14 · Integrity Implants - CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5014
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - 2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025
FDA Device · Class II · 2022-12-14 · Bunnell - Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel - CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
FDA Device · Class II · 2022-12-14 · Philips North America - Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE
FDA Device · Class II · 2022-12-14 · Full Vision - CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF…
FDA Device · Class II · 2022-12-14 · Cardinal Health - Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from…
FDA Device · Class II · 2022-12-14 · Cardinal Health - CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6" (150MM), REF F-52000
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (2…
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel - Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Chargin…
FDA Device · Class II · 2022-12-14 · Insulet - Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
FDA Device · Class II · 2022-12-14 · Cardinal Health - CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
FDA Device · Class I · 2022-12-14 · Caire - CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STRAIGHT, INSULATED OVERALL LENGTH 8-3/4" (225MM), R…
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5…
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
FDA Device · Class I · 2022-12-14 · Dewei Medical Equipment - Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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)