Medicines & devicesClass II
BioMed Laboratories, LLC. recalls Medline Remedy Specialized Silicone Cream (Hydraguard-D )
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
· FDA · Nationwide
Recalls
Safety recalls that rarely make the news, straight from the official U.S. agency records (FDA, USDA, CPSC, NHTSA). Every listing links to its official notice. We only copy what the record says.
Checked Nov 2, 11:30 PM ET · refreshed about every 2.5 hours · RSS · Get recall alerts
FDA drug and medical device recalls.
State filter: shows recalls whose official distribution lists that state, plus nationwide ones. CPSC and NHTSA recalls apply nationwide.
321 recalls for “AI”
Medicines & devicesClass II
CareFusion 213, LLC recalls 10 products
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
· FDA · Nationwide
Medicines & devicesClass II
Oxos Medical Inc recalls Brand Name: OXOS Medical
Due to a defective circuit board that overheats
· FDA · Nationwide
Medicines & devicesClass II
Boston Scientific Corporation recalls 4 products
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve d
· FDA · Nationwide
Medicines & devicesClass II
Boston Scientific Corporation recalls 3 products
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
· FDA
Medicines & devicesClass II
Medline Industries, LP recalls 4 products
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
· FDA · 10 states
Medicines & devicesClass I
Abiomed, Inc. recalls 13 products
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or
· FDA · Nationwide
Medicines & devicesClass II
Orthofix U.S. LLC recalls 4 products
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
· FDA · 26 states
Medicines & devicesClass II
Medline Industries, LP recalls 2 products
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant exten
· FDA · Nationwide
Medicines & devicesClass IIUpdated
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot
· FDA · Nationwide
Medicines & devicesClass II
Asclemed USA Inc. recalls 2 products
Lack of Assurance of Sterility
· FDA · Nationwide
Medicines & devicesClass II
Stryker Corporation recalls 5 products
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
· FDA · Nationwide
Medicines & devicesClass I
Medline Industries, LP recalls 2 products
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
· FDA · CO, IL
Medicines & devicesClass II
Medline Industries, LP recalls 9 products
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary
· FDA · Nationwide
Medicines & devicesClass II
Micro Therapeutics, Inc. recalls 2 products
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
· FDA · Nationwide
Medicines & devicesClass II
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
· FDA · Nationwide
Medicines & devicesClass II
ONESOURCE SPECIALTY PHARMA LIMITED recalls Methohexital Sodium for Injection
Failed Impurities/Degradation Specifications
· FDA · Nationwide
Medicines & devicesClass I
Medline Industries, LP recalls 3 products
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their sup
· FDA · AZ, CA, FL, IL, IN, NJ, OH, SC
Medicines & devicesClass II
GE Medical Systems, LLC recalls 3 products
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. I
· FDA · Nationwide
Medicines & devicesClass II
Integra LifeSciences Corp. (NeuroSciences) recalls OmniTract Surgical Retractor System
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the
· FDA · Nationwide
Medicines & devicesClass II
Medela Inc recalls Brand Name: Medela Product Name: ENFit ExSet Strl 60 2
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
· FDA · 18 states
Medicines & devicesClass II
Spacelabs Healthcare, Inc. recalls Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Prod
Due to off-the-shelf display port component that has audio/video failures
· FDA · Nationwide
Medicines & devicesClass II
Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
· FDA · Nationwide
Medicines & devicesClass II
Remel, Inc recalls GC Agar Base (150mm) 10/PK R04030
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
· FDA · Nationwide
Medicines & devicesClass III
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
· FDA · Nationwide
Medicines & devicesClass I
Argon Medical Devices, Inc recalls 6 products
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
· FDA · Nationwide
Medicines & devicesClass II
Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
· FDA · Nationwide
Medicines & devicesClass II
Emano Metrics, Inc. recalls Emano Flow with software version v2
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 3 products
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 d
· FDA · Nationwide
Medicines & devicesClass II
Medline Industries, LP recalls 8 products
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances
· FDA · Nationwide
Recall data comes from official U.S. government sources: openFDA (food, drugs, devices), USDA FSIS (meat, poultry, egg products), CPSC (consumer and children’s products) and NHTSA (vehicles, equipment, car seats). openFDA notes its data should not be relied on for medical decisions. Always confirm with the official notice. Check your vehicle by VIN at nhtsa.gov/recalls.