FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 2 of 30

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB; 3) CATH LAB ENDO AAA, Medline product number/SKU DYNJ35312I; 4) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AA.
Medline Industries, LP · Northfield, IL

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Reported Oct 21, 2026 · Z-0174-2027

Class IIDeviceOngoing
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.
Medtronic Sofamor Danek USA Inc · Memphis, TN

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

Reported Oct 21, 2026 · Z-0137-2027

Class IIDeviceOngoing
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
BioFire Diagnostics, LLC · Salt Lake City, UT

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Reported Oct 21, 2026 · Z-0150-2027

Class IDeviceOngoing
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Instrumentation Laboratory · Bedford, MA

Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

Reported Oct 21, 2026 · Z-0001-2027

Class IIDeviceOngoing
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through R19; System, Image Processing, Radiological
INTELERAD MEDICAL SYSTEMS INCORPORATED · Montreal

Following a Chromium-based web-browser, report and displayed images may not match.

Reported Oct 21, 2026 · Z-0186-2027

Class IIDeviceOngoing
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
Howmedica Osteonics Corp. · Mahwah, NJ

Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.

Reported Oct 21, 2026 · Z-0165-2027

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.
Medline Industries, LP · Northfield, IL

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Reported Oct 21, 2026 · Z-0175-2027

Class IIDeviceOngoing
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Medline Industries, LP · Northfield, IL

Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Reported Oct 21, 2026 · Z-0185-2027

Class IIDeviceOngoing
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.
Radiometer Medical ApS · Bronshoj

In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.

Reported Oct 21, 2026 · Z-0190-2027

Class IIDeviceOngoing
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
Cadwell Industries Inc · Kennewick, WA

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.

Reported Oct 21, 2026 · Z-0141-2027

Class IIDeviceOngoing
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
SI-BONE, Inc. · Santa Clara, CA

The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.

Reported Oct 21, 2026 · Z-0146-2027

Class IIDeviceOngoing
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
In2bones USA, LLC · Cordova, TN

Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

Reported Oct 21, 2026 · Z-0157-2027

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU DYNJ67139D; 5) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AD; 6) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333K; 7) EXTREMITY-LF, Medline Product Number/SKU DYNJ905276F; 8) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AC; 9) SPINAL CDS, Medline Product Number/SKU CDS940087AL; 10) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697A; 11) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055; 12) CRANIOTOMY-RICHMOND, Medline Product Number/SKU CDS980929U; 13) ACB EXTRAS PACK-6211, Medline Product Number/SKU DYNJ49516; 14) SPINAL CDS, Medline Product Number/SKU CDS940087AK; 15) SPINAL CDS, Medline Product Number/SKU CDS940087AJ; 16) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AB; 17) SPINAL CDS, Medline Product Number/SKU CDS940087AI; 18) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333J; 19) SPINAL CDS, Medline Product Number/SKU CDS940087AG; 20) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AA.
Medline Industries, LP · Northfield, IL

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Reported Oct 21, 2026 · Z-0179-2027

Class IIDeviceOngoing
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683
Beckman Coulter, Inc. · Miami, FL

The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.

Reported Oct 21, 2026 · Z-0161-2027

Class IIDeviceOngoing
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Jenavalve Technology Inc. · Irvine, CA

Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Reported Oct 21, 2026 · Z-0136-2027

Class IIDeviceOngoing
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Steris Corporation · Mentor, OH

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.

Reported Oct 21, 2026 · Z-0154-2027

Class IIDeviceOngoing
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP
Microgenics Corporation · Fremont, CA

Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.

Reported Oct 21, 2026 · Z-0159-2027

Class IIDeviceOngoing
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.
W L Gore & Associates, Inc. · Flagstaff, AZ

The potential for the devices to be mislabeled with the incorrect length.

Reported Oct 21, 2026 · Z-0158-2027

Class IIDeviceOngoing
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Jenavalve Technology Inc. · Irvine, CA

Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Reported Oct 21, 2026 · Z-0135-2027

Class IIDeviceOngoing
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Ethicon, LLC · San Lorenzo, PR

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.

Reported Oct 21, 2026 · Z-0153-2027

Class IIDeviceOngoing
Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline product number/SKU DYNJ900454C; 4) VEIN PACK SHD, Medline product number/SKU DYNJ68420D; 5) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692J; 6) PRODUCT VASCULAR LAFAYETTE, Medline product number/SKU DYNJ908620D; 7) CHRISTUS SPOHN AV ACCESS PACK, Medline product number/SKU DYNJ60973A; 8) TOL VEIN PACK, Medline product number/SKU DYNJ80861F; 9) THROMBECTOMY PACK-LF, Medline product number/SKU DYNJ0160348B; 10) VEIN PACK, Medline product number/SKU DYNJ67308A; 11) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692I; 12) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692G; 13) BYPASS ACCESSORY, Medline product number/SKU DYNJ52036F; 14) TOL VEIN PACK, Medline product number/SKU DYNJ80861C; 15) MANSFIELD ACCESS GRAFT, Medline product number/SKU DYNJ909985; 16) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732I; 17) CAROTID ENDARTERECTOMY PK, Medline product number/SKU DYNJ85516; 18) RADIAL ARTERY PACK, Medline product number/SKU DYNJ83938; 19) AV FISTULA PACK, Medline product number/SKU DYNJ01966N; 20) FH A V FISTULA PACK-LF, Medline product number/SKU DYNJ51804G; 21) VEIN PACK SHD, Medline product number/SKU DYNJ68420C; 22) VEIN PACK SHD, Medline product number/SKU DYNJ68420B; 23) AV FISTULA, Medline product number/SKU DYNJ906945; 24) VEIN PACK SHD, Medline product number/SKU DYNJ68420A; 25) MHC AV FISTULA, Medline product number/SKU DYNJ903705G.
Medline Industries, LP · Northfield, IL

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Reported Oct 21, 2026 · Z-0171-2027

Class IIDeviceOngoing
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Steris Corporation · Mentor, OH

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.

Reported Oct 21, 2026 · Z-0156-2027

Class IIDeviceOngoing
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
INTEGRATED MEDCRAFT LLC · East Hampton, CT

Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.

Reported Oct 21, 2026 · Z-0147-2027

Class IIDeviceOngoing
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
BioFire Diagnostics, LLC · Salt Lake City, UT

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Reported Oct 21, 2026 · Z-0149-2027

Class IIDeviceOngoing
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528P; 5) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312J; 6) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312K; 7) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ43937; 8) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ80549D; 9) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879; 10) Product Name CV PART 1 AND 2, Medline Kit Number/SKU DYNJ908879C; 11) Product Name CARDIAC SURGERY, Medline Kit Number/SKU DYNJ911589A; 12) Product Name AV SHUNT-MARYVIEW, Medline Kit Number/SKU DYNJ911710; 13) Product Name CARDIAC ACCESSORY PACK, Medline Kit Number/SKU DYNJT7607.
Medline Industries, LP · Northfield, IL

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Reported Oct 21, 2026 · Z-0169-2027

Class IIDeviceOngoing
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
Medline Industries, LP · Northfield, IL

Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Reported Oct 21, 2026 · Z-0182-2027

Class IIDeviceOngoing
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Sarnova HC, Llc · Dublin, OH

Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.

Reported Oct 21, 2026 · Z-0144-2027

Class IIDeviceOngoing
Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI PROSTATE ACCESSORY DYNJ63392D UROLOGY LAPAROSCOPIC - 51638 DYNJ908720B UROLOGY ROBOT ADD ON PACK DYNJ85189
Medline Industries, LP · Northfield, IL

Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Reported Oct 21, 2026 · Z-0181-2027

Class IIDeviceOngoing
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Becton Dickinson & Co. · Sparks, MD

Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.

Reported Oct 21, 2026 · Z-0139-2027

Class IIDeviceOngoing
Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD 5/64 X 3/4, Model Number 09-1-012; 5) VENTED INSTRUMENT GUARD 7/64 X 3/4 - GREEN, Model Number 09-1-013; 6) GREEN VENTED INSTRUMENT GUARD 7/64 X 3/4, Model Number 09-1-013; 7) VENTED INSTRUMENT GUARD 1/8 X 1 - RED, Model Number 09-1-014; 8) RED VENTED INSTRUMENT GUARD 1/8 X 1, Model Number 09-1-014; 9) VENTED INSTRUMENT GUARD 3/16 X 1 - YELLOW, Model Number 09-1-015; 10) YELLOW VENTED INSTRUMENT GUARD 3/16 X 1, Model Number 09-1-015; 11) VENTED INSTRUMENT GUARD 13/32 X 3/4 - MAROON, Model Number 09-1-016; 12) MAROON VENTED INSTRUMENT GUARD 13/32 X 3/4, Model Number 09-1-016; 13) MAROON VENTED INSTRU GUARD 13/32 X 3/4, Model Number 09-1-016; 14) VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1 - ORANGE, Model Number 09-1-017; 15) ORANGE VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 16) OR VENTED INSTRU GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 17) VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1 - BROWN, Model Number 09-1-018; 18) BROWN VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 19) BROWN VENTED INSTRU GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 20) VENTED INSTRUMENT GUARD 1/8 X 1 X 1 - BLACK, Model Number 09-1-019; 21) BLACK VENTED INSTRUMENT GUARD 1/8 X 1 X 1, Model Number 09-1-019; 22) BLACK VENTED INSTRU GUARD 1/8 X 1 X 1, Model Number 09-1-019; 23) OPAQUE ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 24) OPAQUE COLOR - ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 25) VENTED INSTRUMENT GUARD 1/16 X 3/4 - TRANSPARENT BLUE, Model Number 09-2-011;
Healthmark Industries Co., Inc. · Fraser, MI

Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.

Reported Oct 21, 2026 · Z-0188-2027

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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.