Medical DeviceAug 25, 2021
Delta Med SpA DELTAVEN Safety I.V recall — FDA Z-2295-2021
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Class IIFDA: OngoingDelta Med SpA
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 482
24,239 detailed records are currently available in this category.
Medical DeviceAug 25, 2021
Olympus Corporation of the Americas Soltive Premium Super Pulsed Laser System (TFL-PLS) & recall — FDA Z-2294-2021
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceAug 25, 2021
Howmedica Osteonics Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 recall — FDA Z-2329-2021
The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents…
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceAug 25, 2021
Philips Ultrasound EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W recall — FDA Z-2306-2021
Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving…
Class IIFDA: CompletedPhilips Ultrasound Inc.
Medical DeviceAug 25, 2021
Philips Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray recall — FDA Z-2315-2021
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceAug 25, 2021
Ostial FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA recall — FDA Z-2309-2021
Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.
Class IIFDA: TerminatedOstial Corporation
Medical DeviceAug 25, 2021
Boston Scientific TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) recall — FDA Z-2328-2021
Potential for leaks and loosening at the patient catheter connection
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceAug 25, 2021
Delta Med SpA DELTAVEN FASTFLASH, Safety I.V recall — FDA Z-2297-2021
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Class IIFDA: OngoingDelta Med SpA
Medical DeviceAug 25, 2021
Delta Med SpA DELTAVEN Y, Safety I.V recall — FDA Z-2298-2021
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Class IIFDA: OngoingDelta Med SpA
Medical DeviceAug 25, 2021
Ethicon Endo-Surgery ECHELON FLEX Powered Plus Stapler-intended for transection, resection recall — FDA Z-2326-2021
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Class IIFDA: TerminatedEthicon Endo-Surgery Inc.
Medical DeviceAug 25, 2021
CooperSurgical Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 recall — FDA Z-2307-2021
Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between…
Class IIFDA: TerminatedCooperSurgical, Inc.
Medical DeviceAug 25, 2021
Philips Respironics Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B recall — FDA Z-2287-2021
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second…
Class IIFDA: OngoingPhilips Respironics, Inc.
Medical DeviceAug 25, 2021
Ortho8 EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis recall — FDA Z-2325-2021
EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Class IIFDA: OngoingOrtho8, Inc.
Medical DeviceAug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1125 recall — FDA Z-2190-2021
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events…
Class IFDA: OngoingHeartware, Inc.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Prime Fifth Wheel Stretcher-stretcher may be used for recall — FDA Z-2207-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Shent USA Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm recall — FDA Z-2230-2021
Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm…
Class IIFDA: CompletedShent USA, Inc.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Proform- support surface is used to assist in the recall — FDA Z-2211-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Abbott Laboratories Alinity s System REF 06P16-01 recall — FDA Z-2276-2021
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Class IIFDA: OngoingAbbott Laboratories, Inc.
Medical DeviceAug 18, 2021
BioMerieux SA MYLA software. Used to manage microbiology test workflow from the reception of recall — FDA Z-2225-2021
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Class IIFDA: TerminatedBioMerieux SA
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number recall — FDA Z-2260-2021
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number recall — FDA Z-2259-2021
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceAug 18, 2021
Shent USA Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm recall — FDA Z-2229-2021
Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm…
Class IIFDA: CompletedShent USA, Inc.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Prime Big Wheel Stretcher-used as a short-term recall — FDA Z-2208-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Bard Peripheral Vascular TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with recall — FDA Z-2247-2021
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.