Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 169 of 548
FDA Devices Moderate Sep 22, 2021
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite …
CAREFUSION
FDA Devices Moderate Sep 22, 2021
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 15, 2021
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Angiodynamics, Inc.
FDA Devices Moderate Sep 15, 2021
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional imag…
Philips North America Llc
FDA Devices Critical Sep 15, 2021
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Micro Therapeutics Inc,
FDA Devices Moderate Sep 15, 2021
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce…
Philips North America Llc
FDA Devices Moderate Sep 15, 2021
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to …
NIHON KOHDEN ORANGEMED, INC
FDA Devices Moderate Sep 15, 2021
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to tr…
Ion Beam Applications S.A.
FDA Devices Moderate Sep 15, 2021
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human se…
Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Sep 15, 2021
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 …
Olympus Corporation of the Americas
FDA Devices Moderate Sep 15, 2021
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Angiodynamics, Inc.
FDA Devices Moderate Sep 15, 2021
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090…
Mivi Neuroscience Inc
FDA Devices Moderate Sep 15, 2021
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9…
Mivi Neuroscience Inc
FDA Devices Moderate Sep 15, 2021
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional im…
Philips North America Llc
FDA Devices Critical Sep 15, 2021
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Athena Medical Products Inc
FDA Devices Moderate Sep 15, 2021
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images…
Philips North America Llc
FDA Devices Moderate Sep 15, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional imag…
Philips North America Llc
FDA Devices Moderate Sep 15, 2021
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional im…
Philips North America Llc
FDA Devices Critical Sep 15, 2021
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Smiths Medical ASD Inc.
FDA Devices Moderate Sep 15, 2021
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional i…
Philips North America Llc
FDA Devices Moderate Sep 15, 2021
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29…
Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Sep 15, 2021
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-section…
Philips North America Llc
FDA Devices Critical Sep 15, 2021
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Smiths Medical ASD Inc.
FDA Drug Moderate Sep 8, 2021
CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC …
China Gel Inc
FDA Drug Moderate Sep 8, 2021
CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 …
China Gel Inc
FDA Drug Moderate Sep 8, 2021
aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; …
China Gel Inc
FDA Devices Moderate Sep 8, 2021
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Aspen Surgical Products, Inc.
FDA Devices Moderate Sep 8, 2021
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal repl…
Baxter Healthcare Corporation
FDA Devices Moderate Sep 8, 2021
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 …
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 8, 2021
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole bl…
Versea Diagnostics LLC
FDA Devices Moderate Sep 8, 2021
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …
DePuy Orthopaedics, Inc.
FDA Devices Moderate Sep 8, 2021
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …
DePuy Orthopaedics, Inc.
FDA Devices Moderate Sep 8, 2021
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Covidien, LP
FDA Devices Moderate Sep 8, 2021
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Thera Test Laboratories, Inc.
FDA Devices Moderate Sep 8, 2021
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Thera Test Laboratories, Inc.
FDA Devices Moderate Sep 8, 2021
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Merge Healthcare, Inc.
FDA Devices Moderate Sep 8, 2021
Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Clarus Medical, Llc
FDA Devices Moderate Sep 8, 2021
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist i…
DePuy Orthopaedics, Inc.
FDA Devices Moderate Sep 8, 2021
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Covidien, LP
FDA Devices Moderate Sep 8, 2021
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
Covidien, LP