Open, ClassifiedPosted Nov 20, 2024·Initiated Oct 10, 2024
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software
Model Number: 1149418
Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
Reason: A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.
Root cause: Software design
Recalling firm: Philips Medical Systems Technologies Ltd.Type: System, Image Processing, RadiologicalDistribution: US Nationwide and Worldwide Distribution
Foreign:
Country
Argentina
Australia
Austria
Belgium
Brazil
Chile
China
Colombia
Denmark
Finland
France
Germany
Gibraltar
Greece
Guernsey
Holy See (Vatican City State)
Hong Kong
Hungary
Indonesia
Ireland
Israel
Italy
Japan
Jersey
Jordan
Lebanon
Malaysia
Mexico
Netherlands
New Zealand
Norway
Oman
Panama
Philippines
Poland
Portugal
Romania
Saudi Arabia
Serbia
Slovenia
Spain
Sweden
Switzerland
Taiwan
Thailand
United KingdomRecall #Z-0497-2025
Open, ClassifiedPosted Nov 20, 2024·Initiated Sep 18, 2024
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190
Product Name: Olympus GIF-1TH190
Model/Catalog Number: GIF-1TH190
Software Version: N/A
Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Reason: To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
Root cause: Reprocessing Controls
Recalling firm: Olympus Corporation of the AmericasType: Gastroscope And Accessories, Flexible/RigidDistribution: Domestic: US Nationwide Distribution.Recall #Z-0498-2025
Open, ClassifiedPosted Nov 19, 2024·Initiated Oct 8, 2024
MONOCRYL" (poliglecaprone 25) Suture REF Y936H
MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
Reason: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Root cause: Process control
Recalling firm: ETHICON, INC.Type: Suture, Absorbable, SyntheticDistribution: U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
O.U.S.: Not provided.Recall #Z-0487-2025
Open, ClassifiedPosted Nov 19, 2024·Initiated Sep 6, 2024
EnChroma Safety Glasses with Rx Indoor Universal Lenses:
Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx;
Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx;
Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx
Reason: Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing a risk of eye injury.
Root cause: Device Design
Recalling firm: Enchroma IncType: Lens, Prescription, Color DeficiencyDistribution: Worldwide distribution: US (nationwide): IL, OH, NC, IA, AL, SC, NJ, TX, CO, PA, FL, MI, NY, DU, NM, CA, NH, MT, WV, KY, OR, MA, WI, VA, AZ and OUS (foreign): United Arab Emirates, Japan, and Canada.Recall #Z-0488-2025
Open, ClassifiedPosted Nov 19, 2024·Initiated Oct 17, 2024
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Reason: Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Root cause: Under Investigation by firm
Recalling firm: Roche Diagnostics Operations, Inc.Type: Urinary Homocystine (Nonquantitative) Test SystemDistribution: US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,Recall #Z-0489-2025
Open, ClassifiedPosted Nov 19, 2024·Initiated Oct 15, 2024
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;
b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR;
c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR;
d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.
Reason: Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Root cause: Use error
Recalling firm: Alcon Research LLCType: Eye TrayDistribution: US distribution to states of: Delaware, Illinois, and OklahomaRecall #Z-0490-2025
Open, ClassifiedPosted Nov 18, 2024·Initiated Sep 19, 2024
NovoHip Biolox Ball Head 32mmL
Ref: 1345-2803
NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components.
Reason: Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
Root cause: Mixed-up of materials/components
Recalling firm: Novosource, LLCType: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedDistribution: Florida, West VirginiaRecall #Z-0483-2025
Open, ClassifiedPosted Nov 18, 2024·Initiated Oct 16, 2024
Acrobat-i Positioner. Model Number C-XP-5000Z
Reason: Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Root cause: Process change control
Recalling firm: Maquet Cardiovascular, LLCType: Stabilizer, HeartDistribution: Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.Recall #Z-0484-2025
Open, ClassifiedPosted Nov 18, 2024·Initiated Oct 16, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Reason: Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Root cause: Process change control
Recalling firm: Maquet Cardiovascular, LLCType: Stabilizer, HeartDistribution: Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.Recall #Z-0485-2025
Open, ClassifiedPosted Nov 18, 2024·Initiated Oct 16, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Reason: Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Root cause: Process change control
Recalling firm: Maquet Cardiovascular, LLCType: Stabilizer, HeartDistribution: Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.Recall #Z-0486-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Jun 26, 2024
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Reason: The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.
Root cause: Device Design
Recalling firm: Smiths Medical ASD, Inc.Type: Pump, Infusion, PcaDistribution: Worldwide distribution.Recall #Z-0466-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Sep 30, 2024
Bard Marquee Disposable Core Biopsy Instrument Kit:
BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210;
BARD MARQUEE 12G X 10 CM, REF: MQ1210;
BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213;
BARD MARQUEE 12G X 13 CM, REF: MQ1213
Reason: Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.
Root cause: Process change control
Recalling firm: Bard Peripheral Vascular IncType: Instrument, BiopsyDistribution: Worldwide - US Nationwide including in the states of WA, LA, MN, PA, UT, SC, OK, KY, AZ, IL, TX, NJ, NY, FL, TN, IN, OH, NC, CO, VA, GA, MD, CA, AL, WI, MO, IA, CT, NE, MI, MS, NV, KS, OR, SD, ID, NH, RI, WY, AR, MA, DE, ND, NM, AK, PR and the countries of Portugal, Spain, South Africa, Greece, United Arab Emirates, United Kingdom, Sweden, Finland, Belgium, Korea, Australia, Canada.Recall #Z-0467-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Oct 4, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Reason: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the
needle.
Root cause: Process change control
Recalling firm: Hobbs Medical, Inc.Type: Endoscopic Injection Needle, Gastroenterology-UrologyDistribution: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.Recall #Z-0468-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Oct 4, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
Reason: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the
needle.
Root cause: Process change control
Recalling firm: Hobbs Medical, Inc.Type: Endoscopic Injection Needle, Gastroenterology-UrologyDistribution: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.Recall #Z-0469-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Oct 4, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
Reason: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the
needle.
Root cause: Process change control
Recalling firm: Hobbs Medical, Inc.Type: Endoscopic Injection Needle, Gastroenterology-UrologyDistribution: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.Recall #Z-0470-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Oct 4, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Reason: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the
needle.
Root cause: Process change control
Recalling firm: Hobbs Medical, Inc.Type: Endoscopic Injection Needle, Gastroenterology-UrologyDistribution: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.Recall #Z-0471-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Oct 4, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Reason: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the
needle.
Root cause: Process change control
Recalling firm: Hobbs Medical, Inc.Type: Endoscopic Injection Needle, Gastroenterology-UrologyDistribution: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.Recall #Z-0472-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Oct 4, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Reason: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the
needle.
Root cause: Process change control
Recalling firm: Hobbs Medical, Inc.Type: Endoscopic Injection Needle, Gastroenterology-UrologyDistribution: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.Recall #Z-0473-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Oct 4, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Reason: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the
needle.
Root cause: Process change control
Recalling firm: Hobbs Medical, Inc.Type: Endoscopic Injection Needle, Gastroenterology-UrologyDistribution: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.Recall #Z-0474-2025
Open, ClassifiedPosted Nov 15, 2024·Initiated Oct 4, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Reason: Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the
needle.
Root cause: Process change control
Recalling firm: Hobbs Medical, Inc.Type: Endoscopic Injection Needle, Gastroenterology-UrologyDistribution: Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.Recall #Z-0475-2025