Medical DeviceMar 25, 2020
Arthrex Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is recall — FDA Z-1510-2020
Screws provided in the device package are 6 mm longer than intended.
Class IIFDA: TerminatedArthrex, Inc.
Latest records
Latest recalls — page 1055
The newest recall records with useful source details are listed here.
Medical DeviceMar 25, 2020
The Binding Site Group Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro recall — FDA Z-1500-2020
It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal…
Class IIFDA: TerminatedThe Binding Site Group, Ltd.
Medical DeviceMar 25, 2020
TeDan Surgical Innovations DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE recall — FDA Z-1505-2020
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product…
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceMar 25, 2020
Philips Poly G Integris H5000, System code 72246 recall — FDA Z-1491-2020
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 25, 2020
Philips MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 recall — FDA Z-1489-2020
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 25, 2020
Avid Medical Custom procedure trays containing medical components needed to facilitate recall — FDA Z-1522-2020
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no…
Class IIFDA: TerminatedAvid Medical, Inc.
Medical DeviceMar 25, 2020
Philips HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M recall — FDA Z-1499-2020
Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or…
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 25, 2020
Avid Medical Custom procedure trays containing medical components needed to facilitate recall — FDA Z-1515-2020
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no…
Class IIFDA: TerminatedAvid Medical, Inc.
Medical DeviceMar 25, 2020
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545 recall — FDA Z-1474-2020
Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than…
Class IFDA: TerminatedCME America, LLC
Medical DeviceMar 25, 2020
Philips Integris Allura 15 & 12, monoplane (system code 722043) and biplane recall — FDA Z-1487-2020
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 25, 2020
Stryker recall — FDA Z-1509-2020
Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could…
Class IIFDA: TerminatedStryker Corporation
Medical DeviceMar 25, 2020
Siemens Medical Solutions USA Ysio, model no. 10281013 Product Usage: The product is a recall — FDA Z-1501-2020
The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMar 25, 2020
Siemens Healthcare Diagnostics IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) recall — FDA Z-1513-2020
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 25, 2020
Deroyal Industries, Inc. Lafollette Teleflex Pilling Aortic Punch, 4.0mm recall — FDA Z-1483-2020
The sterile packaging has the potential to be compromised.
Class IIFDA: TerminatedDeroyal Industries, Inc. Lafollette
Medical DeviceMar 25, 2020
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston recall — FDA Z-1511-2020
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these…
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceMar 25, 2020
Philips OmniDiagnost Eleva System codes 708028 708027 recall — FDA Z-1490-2020
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 25, 2020
Aesculap Implant Systems COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components recall — FDA Z-1479-2020
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceMar 25, 2020
Aesculap Implant Systems COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components recall — FDA Z-1480-2020
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceMar 25, 2020
Siemens Medical Solutions USA Artis Q Biplane, Model No. 10848282 recall — FDA Z-1495-2020
A software issue could potentially cause the stand and table movements to be blocked.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMar 25, 2020
Avid Medical Custom procedure trays containing medical components needed to facilitate recall — FDA Z-1518-2020
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no…
Class IIFDA: TerminatedAvid Medical, Inc.
Medical DeviceMar 25, 2020
TeDan Surgical Innovations D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product recall — FDA Z-1504-2020
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product…
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceMar 25, 2020
Aesculap Implant Systems Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant recall — FDA Z-1478-2020
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceMar 25, 2020
Avid Medical Custom procedure trays containing medical components needed to facilitate recall — FDA Z-1523-2020
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no…
Class IIFDA: TerminatedAvid Medical, Inc.
Medical DeviceMar 25, 2020
Philips UroDiagnost Eleva, system code 708033 recall — FDA Z-1492-2020
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class IIFDA: TerminatedPhilips North America, LLC
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026180 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories