FDA•MODERATE
GE Healthcare AW Server 3.2 ext.6.5
GE Healthcare is recalling the AW Server 3.2 ext.6.5 image processing system due to a software error that may display the wrong patient's data.
Filters
Category
Agency
Severity
Date
Distributed in
All Recalls
Back to home ←
FDA•MODERATEOctopus Evolution Tissue StabilizerMedtronic recalls Octopus Evolution Tissue Stabilizer TS2000 due to incorrect tubing assembly.
3 products
FDA•MODERATESurgify Halo BurrSurgify Halo 3.0 mm burr recalled due to potential breakage during spinal surgery.
19 products
FDA•MODERATEStryker InZone Detachment SystemStryker is recalling the InZone Detachment System due to premature battery drain that may prevent coil detachment during medical procedures.
FDA•MODERATEDuloxetine Delayed-Release CapsulesDirect Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.
FDA•MODERATEAcumed Hexalobe ScrewsAcumed is recalling various hexalobe screws used in wrist fixation systems due to a risk of the screws breaking during use.
2 products
FDA•MODERATEAmgen Corlanor and Sensipar TabletsAmgen recalls Corlanor and Sensipar tablets over foreign substance contamination.
5 products
FDA•MODERATEZimmer Off-Axis Reamer GuideZimmer recalls Off-Axis Reamer Guide (Model 110040240) due to breakage risk from catching during reaming.
5 products
FDA•MODERATEPFM Medical Multi-Snare SetPFM Medical is recalling Multi-Snare Set catheter devices due to a failure to meet biocompatibility requirements for in-vitro cytotoxicity.
FDA•MODERATEVentec VOCSN+Pro Respiratory SystemVentec is recalling the VOCSN+Pro respiratory system because a damaged battery may prevent the backup alarm from sounding during power loss.
FDA•MODERATEMethylergonovine Maleate TabletsMajor Pharmaceuticals is recalling 0.2 mg Methylergonovine Maleate Tablets due to subpotency.
FDA•MODERATEFenofibrate Capsules, USP 200 mgAjanta Pharma is recalling Fenofibrate Capsules, USP 200 mg, due to manufacturing process deviations.
FDA•MODERATEPhilips Avalon Fetal Monitor FM20Philips recalls Avalon Fetal Monitor FM20 over speaker connector issue that may cause loss of speaker output.
2 products
FDA•MODERATEDa Vinci Surgical System E-Brake Retainer PinIntuitive Surgical is recalling the Da Vinci surgical system E-brake retainer pin due to a risk of uncontrolled motion and patient injury.
FDA•MODERATETMJ Bilateral ImplantsTMJ Solutions is recalling custom temporomandibular joint implants due to incorrect components causing a poor fit and potential open bite.
FDA•MODERATEKeystone Industries: Multiple Topical Anesthetic GelsKeystone recalls 20% benzocaine gels (Pearson, Quala, DHP, etc.) over defective seals.
7 products- Device RecallFDA•MODERATEHeartMate 3 LVAS Backup Battery
Thoratec recalls HeartMate 3 LVAS kits (model 106524US) due to 11V backup battery failures.
6 products 
FDA•MODERATEInspire Respiratory Sensing LeadInspire is recalling its Respiratory Sensing Lead (Model 4340) due to incorrect Use By Dates that may lead to premature revision surgery.
3 products
FDA•MODERATEBD Connecta Luer-Lok StopcockBD is recalling Connecta Luer-Lok stopcocks due to a potential connection failure at Port C when using plastic luer-lok syringes.
FDA•MODERATESplashwire Hydrophilic Guide WireMerit Medical is recalling various Splashwire Hydrophilic Guide Wire models due to unsealed pouches that may compromise device sterility.
2 products
FDA•MODERATEBuprenorphine HCl InjectionPar Health is recalling Buprenorphine HCl Injection due to crystallization identified as Buprenorphine free base.
FDA•MODERATETriathlon Universal Baseplate Size 3/4Stryker recalls Triathlon Universal Baseplates due to size mislabeling in packaging.
2 products
FDA•MODERATEMedline Red Rubber Latex Urethral CathetersMedline recalls Red Rubber Latex Urethral Catheters (REF DYND13508–DYND13522, DYND13614/16) over surface, connector, and diameter defects.
34 products
FDA•MODERATEGiraffe OmniBed Canopy SoffitGE HealthCare recalls Giraffe OmniBed incubator/warmer over canopy soffit fastener risk that could injure patients.
3 products
FDA•MODERATEConMed AirSeal 5 mm Access PortConMed recalls AirSeal 5 mm Access Port (iASB5-150) over overpressure alert risk.
11 products- Device RecallFDA•MODERATESTAAR ICL Calculation Software
Staar Surgical is recalling Version 8.00 of its ICL Calculation Software due to a coding error affecting toric lens orientation diagrams.
2 products 
FDA•MODERATENutrisystem Chocolate CheesecakeNutrisystem is recalling Chocolate Cheesecake 2 oz packages due to an undeclared soy allergen.
FDA•MODERATEGreat Value Hawaiian Roll 4pkGreat Value Hawaiian Roll 4pk recalled over oily substance on food-contact packaging; product never reached store shelves.
FDA•MODERATEdirectCHECK ACT-LR Whole Blood Quality ControlAccriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control, level 2, due to incorrect performance range labeling.
FDA•MODERATEAripiprazole 30 mg TabletsAjanta Pharma is recalling Aripiprazole 30 mg tablets due to a mix-up with Voriconazole 50 mg tablets.
FDA•MODERATEMedtronic O-arm O2 Imaging SystemMedtronic is recalling the O-arm O2 Imaging System due to a firmware anomaly that may cause image artifacts during clinical use.
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemHarmonyAIR A-Series surgical lights recalled: intensity buttons may detach.
2 products
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemSteris is recalling HarmonyAIR A-Series Surgical Lighting Systems due to a risk of paint delamination on the light heads.
FDA•CRITICALNara Organics Whole Milk Organic Infant FormulaNara Organics is recalling Whole Milk Organic Infant Formula over potential Clostridium botulinum contamination.
FDA•MODERATEDabur India: Multiple Made In India ProductsDabur India recalls 14 OTC topical products over CGMP deviations.
14 products
FDA•MODERATEChlorthalidone 25 mg TabletsChlorthalidone 25 mg tablets are being recalled due to failed dissolution specifications.
FDA•LOWFocalin XR 5 mg CapsulesSandoz is recalling Focalin XR 5 mg capsules due to missing or incorrect lot numbers and expiration dates on the product labels.
FDA•MODERATEAlyacen 7/7/7 TabletsGlenmark is recalling Alyacen 7/7/7 tablets due to out-of-specification results for total impurities.
FDA•MODERATEVasopressin 2 Units/2 mL SyringesIntegraDose is recalling Vasopressin 2 Units/2 mL syringes due to subpotency, which may cause the drug to be ineffective.
FDA•MODERATEPAI: Multiple Kerr Insta-char In An ProductsVistaPharm recalls Kerr Insta-Char activated charcoal (25g/50g) for failing OTC monograph requirements.
4 products
FDA•MODERATEMedline EBSI KitMedline recalls EBSI Kit (EBSI1534) due to cracked butyrate tubing and recalled MASTISOL adhesive.
42 products
FDA•CRITICALImpella Heart Pump Software RecallAbbott's Impella heart pumps may fail to restart after certain operational faults, posing a serious health risk to patients.
2 products
FDA•CRITICALParacentesis KitArrow International recalls paracentesis kits due to supplier quality issues with included injectables, risking serious injury.
51 products
FDA•MODERATEHalyard Pain PackAVID Medical recalls Halyard Pain Pack kits (AMPK48-01) over possible lack of sterilization.
4 products
FDA•MODERATEMOSAIQ Oncology Information SystemElekta is recalling the MOSAIQ Oncology Information System due to a software error that may prevent the loading of baseline shift plans.
FDA•MODERATEBoston Scientific Orca Air/Water and Suction ValvesBoston Scientific is recalling Orca single-use air/water and suction valves due to reports of the suction button sticking during use.
- Device RecallFDA•MODERATEMerlin Patient Care System Programmer Software
Abbott Medical is recalling Merlin PCS software for the Model 3330 programmer due to a potential failure to terminate pacing tests.
FDA•MODERATEBoston Scientific Clik X AnchorBoston Scientific is recalling the Clik X Anchor due to a potential lack of sterility assurance.
FDA•MODERATEBoston Scientific CSK ElectrodesBoston Scientific recalls CSK reusable electrodes over performance concerns.
4 products
FDA•LOWPrimidone 50 mg TabletsAmneal Pharmaceuticals is recalling Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API.