Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 18, 2024
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
Reason: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Root cause: Process control
Recalling firm: GE Medical Systems, LLCType: Vaporizer, Anesthesia, Non-HeatedDistribution: US Nationwide. Global Distribution.Recall #Z-0817-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 18, 2024
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Reason: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Root cause: Process control
Recalling firm: GE Medical Systems, LLCType: Vaporizer, Anesthesia, Non-HeatedDistribution: US Nationwide. Global Distribution.Recall #Z-0818-2025
CompletedPosted Jan 7, 2025·Initiated Nov 26, 2024
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Reason: The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
Root cause: Under Investigation by firm
Recalling firm: Applied Medical Technology IncType: Gastrointestinal Tubes With Enteral Specific ConnectorsDistribution: US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WARecall #Z-0819-2025
Open, ClassifiedPosted Jan 6, 2025·Initiated Nov 18, 2024
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS
Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.
Reason: There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System.
Root cause: Device Design
Recalling firm: Elucent Medical IncType: Marker, Radiographic, ImplantableDistribution: US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WIRecall #Z-0806-2025
Open, ClassifiedPosted Jan 6, 2025·Initiated Dec 3, 2024
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000)
120V NEPTUNE S ROVER (0711-001-000)
230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG)
230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
Reason: Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.Recall #Z-0807-2025
Open, ClassifiedPosted Jan 6, 2025·Initiated Nov 12, 2024
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Reason: Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
Root cause: Under Investigation by firm
Recalling firm: Aerin Medical, Inc.Type: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY, NE, NY, OH, OR PA, SC, TN, TX, UT, VA, WA, WI, and WV.Recall #Z-0808-2025
Open, ClassifiedPosted Jan 3, 2025·Initiated Dec 9, 2024
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000.
Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Reason: Potential for two issues:
1. Bent or detached heater wire;
2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Root cause: Device Design
Recalling firm: Maquet Cardiovascular, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Puerto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.Recall #Z-0711-2025
Open, ClassifiedPosted Jan 3, 2025·Initiated Dec 9, 2024
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001.
Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Reason: Potential for two issues:
1. Bent or detached heater wire;
2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Root cause: Device Design
Recalling firm: Maquet Cardiovascular, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Puerto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.Recall #Z-0712-2025
Open, ClassifiedPosted Jan 3, 2025·Initiated Dec 9, 2024
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Reason: Oxygen concentrator may melt or catch on fire during use.
Root cause: Component change control
Recalling firm: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTDType: Generator, Oxygen, PortableDistribution: US: OHRecall #Z-0795-2025
Open, ClassifiedPosted Jan 3, 2025·Initiated Dec 5, 2024
Dialyzer Optiflux 160NRe
Reason: Potential for internal blood leaks due to cracked polyurethane
Root cause: Process control
Recalling firm: Fresenius Medical Care Holdings, Inc.Type: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: Nationwide Distribution.Recall #Z-0801-2025
Open, ClassifiedPosted Jan 3, 2025·Initiated Nov 19, 2024
VACUETTE SAFELINK, REF: 450210
Reason: The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Root cause: Process control
Recalling firm: Greiner Bio-One GmbHType: Needle, Hypodermic, Single LumenDistribution: US Nationwide distribution in the states of IL, PA.Recall #Z-0802-2025
Open, ClassifiedPosted Jan 3, 2025·Initiated Nov 26, 2024
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
Reason: Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.
Root cause: Nonconforming Material/Component
Recalling firm: Beckman Coulter, Inc.Type: Radioimmunoassay, Parathyroid HormoneDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-0803-2025
Open, ClassifiedPosted Jan 3, 2025·Initiated Dec 3, 2024
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
Reason: Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.
Root cause: Labeling Change Control
Recalling firm: Qualigen IncType: Radioimmunoassay, Testosterones And DihydrotestosteroneDistribution: Distribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, and VA. There was no military/government/foreign distribution.Recall #Z-0805-2025
Open, ClassifiedPosted Jan 2, 2025·Initiated Nov 26, 2024
3M Unitek Transbond Plus Self-Etching Primer REF
712-090 (100 unit box)
712-091 (20 unit box)
Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.
Reason: Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Root cause: Process control
Recalling firm: 3M Unitek CorporationType: Agent, Tooth Bonding, ResinDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of : Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican, Republic, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Hong Kong, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherland, New Zealand, Norway, Poland, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, and the United Kingdom.Recall #Z-0797-2025
Open, ClassifiedPosted Jan 2, 2025·Initiated Oct 22, 2024
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site.
Model Number: Q604206
Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Root cause: Equipment maintenance
Recalling firm: Carwild CorporationType: Sponge, OphthalmicDistribution: IL, FL, SC. PA, AL
Foreign: NetherlandsRecall #Z-0798-2025
Open, ClassifiedPosted Jan 2, 2025·Initiated Oct 22, 2024
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During
Ophthalmic Surgical Procedures For Fluid Management
Model Number: Q604237
Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Root cause: Equipment maintenance
Recalling firm: Carwild CorporationType: Sponge, OphthalmicDistribution: IL, FL, SC. PA, AL
Foreign: NetherlandsRecall #Z-0799-2025
Open, ClassifiedPosted Jan 2, 2025·Initiated Oct 22, 2024
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management
Model Number: Q770410
Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Root cause: Equipment maintenance
Recalling firm: Carwild CorporationType: Sponge, OphthalmicDistribution: IL, FL, SC. PA, AL
Foreign: NetherlandsRecall #Z-0800-2025
Open, ClassifiedPosted Dec 31, 2024·Initiated Nov 19, 2024
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
Reason: Incomplete or partial pouch seals, which may result in a breach in the sterility.
Root cause: Process control
Recalling firm: Med Michigan Holding LlcType: Apparatus, Suction, Operating-Room, Wall Vacuum PoweredDistribution: Product distributed to a distributor located in IL.Recall #Z-0796-2025
Open, ClassifiedPosted Dec 30, 2024·Initiated Nov 21, 2024
Medline custom medical procedure kits labeled as:
1) CATH LAB PACK-LF, REF DYNJ0382559M;
2) CRANI, REF DYNJ56001B;
3) GENDER AFFIRMING SURGERY, REF DYNJ66252;
4) GENDER AFFIRMING SURGERY, REF DYNJ66252A;
5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
Reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiac Catheterization KitDistribution: Worldwide distribution - US Nationwide and the countries of UAE, and Canada.Recall #Z-0777-2025
Open, ClassifiedPosted Dec 30, 2024·Initiated Nov 21, 2024
Medline custom medical procedure kits labeled as:
1) OPEN HEART CDS-LF, REFCDS840451M;
2) NEURO PACK, REFDYNJ41516M;
3) RFD- AAA PACK, REFDYNJ54242B;
4) OPEN HEART A&B, REFDYNJ901203C;
5) OPEN HEART A&B, REFDYNJ901203D;
6) ACDF-LF, REFDYNJ906681B;
7) ACDF-LF, REFDYNJ906681C.
Reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiovascular Procedure KitDistribution: Worldwide distribution - US Nationwide and the countries of UAE, and Canada.Recall #Z-0778-2025