Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 140 of 548
FDA Devices Moderate Oct 19, 2022
Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519
Hobbs Medical, Inc.
FDA Devices Moderate Oct 19, 2022
Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY
Hobbs Medical, Inc.
FDA Devices Moderate Oct 19, 2022
Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518
Hobbs Medical, Inc.
FDA Devices Moderate Oct 19, 2022
Hobbs Medical Grasping Forceps Catalog Number: 5008
Hobbs Medical, Inc.
FDA Devices Moderate Oct 19, 2022
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Oct 19, 2022
Freeman Pancreatic Flexi-Stent Catalog Number: 6534
Hobbs Medical, Inc.
FDA Devices Moderate Oct 19, 2022
Hobbs Helical Retrieval Basket Catalog Number: 4830
Hobbs Medical, Inc.
CPSC Moderate Oct 13, 2022
Cressi-Sub USA Recalls Scuba Diver Buoyancy Compensator Devices Due to Drowning Hazard
FDA Drug Moderate Oct 12, 2022
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-…
CIPLA
FDA Devices Moderate Oct 12, 2022
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Zimmer, Inc.
FDA Devices Critical Oct 12, 2022
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Fresenius Kabi USA, LLC
FDA Devices Moderate Oct 12, 2022
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
B Braun Medical Inc
FDA Devices Critical Oct 12, 2022
Wisp and Wisp Youth Nasal Mask
Philips Respironics, Inc.
FDA Devices Critical Oct 12, 2022
DreamWisp Nasal Mask with Over the Nose Cushion
Philips Respironics, Inc.
FDA Devices Critical Oct 12, 2022
Philips Respironics Amara View Minimal Contact Full-Face Mask
Philips Respironics, Inc.
FDA Devices Moderate Oct 12, 2022
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Philips North America Llc
FDA Devices Moderate Oct 12, 2022
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised …
Hologic, Inc
FDA Devices Moderate Oct 5, 2022
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 G00455 THS…
Cook Incorporated
FDA Devices Low Oct 5, 2022
SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal…
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Oct 5, 2022
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Micro-X Ltd.
FDA Devices Low Oct 5, 2022
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pa…
Baxter Healthcare Corporation
FDA Devices Low Oct 5, 2022
Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. M…
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Oct 5, 2022
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, …
Collagen Matrix Inc
FDA Devices Moderate Oct 5, 2022
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HT…
Cook Incorporated
FDA Devices Moderate Oct 5, 2022
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G0246…
Cook Incorporated
FDA Devices Low Oct 5, 2022
DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Oct 5, 2022
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Cook Incorporated
FDA Devices Moderate Oct 5, 2022
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Surgical Innovations Ltd
FDA Devices Moderate Oct 5, 2022
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-…
Cook Incorporated
FDA Devices Moderate Oct 5, 2022
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Cook Incorporated
FDA Devices Moderate Oct 5, 2022
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G0…
Cook Incorporated
FDA Devices Moderate Oct 5, 2022
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Cont…
Tandem Diabetes Care Inc
FDA Devices Moderate Oct 5, 2022
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Leica Microsystems, Inc.
FDA Devices Moderate Oct 5, 2022
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Leica Microsystems, Inc.
FDA Devices Low Oct 5, 2022
a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIE…
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Critical Oct 5, 2022
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardio…
Cardiac Assist, Inc
FDA Devices Moderate Oct 5, 2022
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . Me…
CareFusion 303, Inc.
FDA Devices Moderate Oct 5, 2022
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
Cook Incorporated
FDA Devices Moderate Oct 5, 2022
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Cook Incorporated
FDA Devices Moderate Oct 5, 2022
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insul…
Unomedical A/S
FDA Devices Moderate Oct 5, 2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
CooperSurgical, Inc.
FDA Devices Low Oct 5, 2022
DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Oct 5, 2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produ…
CooperSurgical, Inc.
FDA Devices Low Oct 5, 2022
Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B …
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Oct 5, 2022
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
bioMerieux, Inc.
FDA Devices Moderate Oct 5, 2022
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DO…
Cook Incorporated
FDA Devices Moderate Oct 5, 2022
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
MALVERN PANALYTICAL LTD
FDA Devices Moderate Oct 5, 2022
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 P…
Cook Incorporated
FDA Devices Low Oct 5, 2022
a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediam…
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Oct 5, 2022
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
Cook Incorporated