Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIAPI STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIAPI 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIAPI 20 E 25 STRIPS, CATALOG 20100
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIAPI LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBeaver Visitec International, Inc.Class IIBeaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
- 2023-01-11FDA-DeviceSteris CorporationClass IIVERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- 2023-01-11FDA-DeviceSteris CorporationClass IIVERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- 2023-01-11FDA-DeviceSteris CorporationClass IIVERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- 2023-01-11FDA-DeviceSteris CorporationClass IIVERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
- 2023-01-11FDA-DeviceBeckman Coulter, Inc.Class IIBECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
- 2023-01-11FDA-DeviceMedtronic MiniMedClass IIGuardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.
- 2023-01-11FDA-DeviceSiemens Medical Solutions USA, IncClass IIProgrammable Diagnostic Computer
The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;
- 2023-01-11FDA-DeviceENDO Pharmaceuticals Solutions, Inc.Class II9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
No expiration dates printed on the packaging
- 2023-01-04FDA-DeviceTELEFLEX LLCClass IIPilling Wecksorb Cylindrical Sponges
Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
- 2023-01-04FDA-DeviceRemington Medical, Inc.Class IIRemington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
The stylet is longer than specified on the label
- 2023-01-04FDA-DeviceAcumed LLCClass IIDual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-014
Distribution without Pre-Market Clearance
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