Open, ClassifiedPosted Oct 14, 2026·Initiated Sep 8, 2026
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Reason: Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
Root cause: Process control
Recalling firm: Ethicon, LLCType: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileDistribution: Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.Recall #Z-0153-2027
Open, ClassifiedPosted Oct 14, 2026·Initiated Sep 21, 2026
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Reason: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
Root cause: Process change control
Recalling firm: Steris CorporationType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide - US Nationwide distribution.Recall #Z-0154-2027 Open, ClassifiedPosted Oct 14, 2026·Initiated Sep 21, 2026
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Reason: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
Root cause: Process change control
Recalling firm: Steris CorporationType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide - US Nationwide distribution.Recall #Z-0155-2027 Open, ClassifiedPosted Oct 14, 2026·Initiated Sep 21, 2026
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Reason: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
Root cause: Process change control
Recalling firm: Steris CorporationType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide - US Nationwide distribution.Recall #Z-0156-2027 Open, ClassifiedPosted Oct 14, 2026·Initiated Sep 9, 2026
REF: P65 ST862
CoLag SCREW, FT, 6.7X62.5 mm
Reason: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
Root cause: Error in labeling
Recalling firm: In2bones USA, LLCType: Screw, Fixation, BoneDistribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.Recall #Z-0157-2027
Open, ClassifiedPosted Oct 14, 2026·Initiated Sep 3, 2026
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis;
Model/Catalog Number: VSWVH0808 and VSWVN1006
Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
Reason: The potential for the devices to be mislabeled with the incorrect length.
Root cause: Under Investigation by firm
Recalling firm: W L Gore & Associates, Inc.Type: Stents, Drains And Dilators For The Biliary DuctsDistribution: US Nationwide distribution in the states of GA, RI.Recall #Z-0158-2027
Open, ClassifiedPosted Oct 13, 2026·Initiated Aug 12, 2026
Generic Name: FilmArray Pneumonia Panel
Generic Name: FilmArray Pneumonia Panel
Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144).
Software Version: N/A
Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Component: N/A
Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Root cause: Under Investigation by firm
Recalling firm: BioFire Diagnostics, LLCType: Respiratory PanelDistribution: Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.Recall #Z-0148-2027
Open, ClassifiedPosted Oct 13, 2026·Initiated Aug 12, 2026
Generic Name: FilmArray Pneumonia Panel plus
Generic Name: FilmArray Pneumonia Panel plus
Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit)
Software Version: N/A
Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Component: N/A
Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Root cause: Under Investigation by firm
Recalling firm: BioFire Diagnostics, LLCType: Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection SystemDistribution: Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.Recall #Z-0149-2027
Open, ClassifiedPosted Oct 13, 2026·Initiated Aug 12, 2026
Generic Name: BioFire Joint Infection (JI) Panel
Generic Name: BioFire Joint Infection (JI) Panel
Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit)
Software Version: N/A
Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Component: N/A
Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Root cause: Under Investigation by firm
Recalling firm: BioFire Diagnostics, LLCType: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection SystemDistribution: Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.Recall #Z-0150-2027
Open, ClassifiedPosted Oct 13, 2026·Initiated Sep 14, 2026
Likorall Overhead Lifts
Product Code: 3121001
Product Description: LIKORALL 200
Product Code: 3122005
Product Description: LIKORALL 242 ES, NATURAL
Product Code: 3122005NA
Product Description: LIKORALL 242 ES, NATURAL
Product Code: 3122006
Product Description: LIKORALL 242 ES, WHITE
Product Code: 3122006NA
Product Description: LIKORALL 242 ES, WHITE
Product Code: 3122007
Product Description: LIKORALL 242 ES R2R, NATURAL
Product Code: 3122007NA
Product Description: LIKORALL 242 ES R2R, NATURAL
Product Code: 3122008
Product Description: LIKORALL 242 ES R2R, WHITE
Product Code: 3122008NA
Product Description: LIKORALL 242 ES R2R, WHITE
Product Code: 3122009
Product Description: LIKORALL 242 S, NATURAL
Product Code: 3122009NA
Product Description: LIKORALL 242 S, NATURAL
Product Code: 3122010
Product Description: LIKORALL 242 S, WHITE
Product Code: 3122011
Product Description: LIKORALL 242 S R2R, NATURAL
Product Code: 3122011NA
Product Description: LIKORALL 242 S R2R, NATURAL
Product Code: 3122012
Product Description: LIKORALL 242 S R2R, WHITE
Product Code: 3122012NA
Product Description: LIKORALL 242 S R2R, WHITE
Product Code: 3122501
Product Description: LIKORALL 250 ES, NATURAL
Product Code: 3122501NA
Product Description: LIKORALL 250 ES, NATURAL
Product Code: 3122502
Product Description: LIKORALL 250 ES, WHITE
Product Code: 3122502NA
Product Description: LIKORALL 250 ES, WHITE
Product Code: 3123001
Product Description: LIKORALL 243 ES
Product Code: 3123001NA
Product Description: LIKORALL 243 ES
Product Code: 3123002
Product Description: LIKORALL 243 ES, WHITE
Product Code: 3123002NA
Product Description: LIKORALL 243 ES, WHITE
Product Code: 3124050
Product Description: LIKORALL 250 S, IRC
Reason: Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Lift, Patient, Non-Ac-PoweredDistribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. International distribution in pending.Recall #Z-0151-2027
Open, ClassifiedPosted Oct 10, 2026·Initiated Sep 3, 2026
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Root cause: Under Investigation by firm
Recalling firm: Instrumentation LaboratoryType: Platelet Factor 4 RadioimmunoassayDistribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.Recall #Z-0001-2027 Open, ClassifiedPosted Oct 10, 2026·Initiated Sep 3, 2026
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Root cause: Under Investigation by firm
Recalling firm: Instrumentation LaboratoryType: Platelet Factor 4 RadioimmunoassayDistribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.Recall #Z-0002-2027 Open, ClassifiedPosted Oct 9, 2026·Initiated Jul 31, 2026
JenaValve Trilogy Delivery Catheter, Size 23MM
REF: TRILOGY-DC-S
Reason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Root cause: Nonconforming Material/Component
Recalling firm: Jenavalve Technology Inc.Type: Aortic Valve, Prosthesis, Percutaneously DeliveredDistribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.Recall #Z-0134-2027
Open, ClassifiedPosted Oct 9, 2026·Initiated Jul 31, 2026
JenaValve Trilogy Delivery Catheter, Size 25MM
REF: TRILOGY-DC-M
Reason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Root cause: Nonconforming Material/Component
Recalling firm: Jenavalve Technology Inc.Type: Aortic Valve, Prosthesis, Percutaneously DeliveredDistribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.Recall #Z-0135-2027
Open, ClassifiedPosted Oct 9, 2026·Initiated Jul 31, 2026
JenaValve Trilogy Delivery Catheter, Size 27MM
REF: TRILOGY-DC-L
Reason: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.
Root cause: Nonconforming Material/Component
Recalling firm: Jenavalve Technology Inc.Type: Aortic Valve, Prosthesis, Percutaneously DeliveredDistribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.Recall #Z-0136-2027
Open, ClassifiedPosted Oct 9, 2026·Initiated Aug 12, 2026
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue
combined with an inert additive to yield a demineralized bone matrix (DBM)
allograft product having a particular physical form and/or handling property.
Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form
of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch" and Orthoblend are
produced from a fiber form of DBM Crunch" also contains demineralized bone
chips/cubes, while Grafton DBM Orthoblend contains non-demineralized
cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are
malleable and can be molded or cut into various sizes and shapes according to the
intended implant site.
Reason: Medtronic identified through donor record review that the donor for Medtronic
batch A62881 did not meet all Medtronic donor eligibility requirements related to
the presence of microbial organisms. While the batch passed finished product
sterility testing Medtronic is retrieving any unused product manufactured from the
donor tissue.
Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection
Root cause: Process change control
Recalling firm: Medtronic Sofamor Danek USA IncType: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)Distribution: US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.Recall #Z-0137-2027
Open, ClassifiedPosted Oct 9, 2026·Initiated Aug 12, 2026
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue
combined with an inert additive to yield a demineralized bone matrix (DBM)
allograft product having a particular physical form and/or handling property.
Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form
of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch" and Orthoblend are
produced from a fiber form of DBM Crunch" also contains demineralized bone
chips/cubes, while Grafton DBM Orthoblend contains non-demineralized
cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are
malleable and can be molded or cut into various sizes and shapes according to the
intended implant site.
Reason: Medtronic identified through donor record review that the donor for Medtronic
batch A62881 did not meet all Medtronic donor eligibility requirements related to
the presence of microbial organisms. While the batch passed finished product
sterility testing Medtronic is retrieving any unused product manufactured from the
donor tissue.
Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.
Root cause: Process change control
Recalling firm: Medtronic Sofamor Danek USA IncType: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)Distribution: US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.Recall #Z-0138-2027
Open, ClassifiedPosted Oct 9, 2026·Initiated Aug 13, 2026
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Reason: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: US Nationwide distribution.Recall #Z-0139-2027
Open, ClassifiedPosted Oct 9, 2026·Initiated Aug 13, 2026
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Reason: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: US Nationwide distribution.Recall #Z-0140-2027
Open, ClassifiedPosted Oct 9, 2026·Initiated Aug 18, 2026
Brand Name: IOMAX
Product Name: IOMAX Cortical Module
Model/Catalog Number: 190296-200
UDI-DI code: 00840067100653
Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V.
Component: Is the cortical component of the IOMAX system
Reason: Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.
Root cause: Under Investigation by firm
Recalling firm: Cadwell Industries IncType: Stimulator, Electrical, Evoked ResponseDistribution: Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.Recall #Z-0141-2027