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.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious Cysto Packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious Laparoscopy Packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious ENT Packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious PICC Line, Central Line Packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious Pacemaker Packs, Cardio Thoracic Packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious Angiography/Cath Lab packs/trays
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceAmerican Contract Systems, Inc.Class IIVarious Angiography packs/trays
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- 2022-09-14FDA-DeviceStradis HealthcareClass IIVYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Potential for incomplete seals.
- 2022-09-14FDA-DeviceDatascope CorporationClass IIInsertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Certain lots containing undersized dilator.
- 2022-09-14FDA-DeviceDatascope CorporationClass IISensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Certain lots containing undersized dilator.
- 2022-09-14FDA-DeviceDatascope CorporationClass IIMEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Certain lots containing undersized dilator.
- 2022-09-14FDA-DeviceSaranas, Inc.Class IIEarly Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
- 2022-09-14FDA-DeviceMedline Industries Inc.Class IIMedline CHEST TUBE REORDER NO: DYNJ36762A
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
- 2022-09-14FDA-DeviceICU Medical, Inc.Class IIProduct Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger/CL3951; 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock Port, Clamp, Graduated Adapter/CL3967; 6 IN(15cm)APPX 0.82ml,EXT SET,MicroClave Clear,ChemoLock PORT,YCONN, ROTATING LUER/CL41
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
- 2022-09-14FDA-DeviceICU Medical, Inc.Class IIProduct Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150; 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger/CL3011; 9 IN(23cm)APPX 2.7ml,EXT SET,ChemoLock PORT,2 CLAMPS,2 GRADUATED CONN/
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
- 2022-09-14FDA-DeviceBALT USA, LLCClass IIOptima Coil System Model OPTI0520CSF10. For endovascular embolization.
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
- 2022-09-14FDA-DeviceAbbott Molecular, Inc.Class IIAbbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
- 2022-09-14FDA-DeviceOrthoPediatrics CorpClass IIOrthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
- 2022-09-14FDA-DeviceBiosense Webster, Inc.Class IICARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
- 2022-09-14FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
- 2022-09-14FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
- 2022-09-14FDA-DeviceMERCHSOURCE LLCClass IIThe product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Excessive ultraviolet-C radiation
- 2022-09-14FDA-DevicePhilips Respironics, Inc.Class IPhilips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- 2022-09-14FDA-DevicePhilips Respironics, Inc.Class IPhilips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- 2022-09-14FDA-DevicePhilips Respironics, Inc.Class IPhilips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- 2022-09-14FDA-DevicePhilips Respironics, Inc.Class IPhilips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- 2022-09-14FDA-DevicePhilips Respironics, Inc.Class IPhilips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- 2022-09-14FDA-DevicePhilips Respironics, Inc.Class IPhilips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- 2022-09-07FDA-DeviceOculus Optikgeraete GMBHClass IIPentacam HR REF 70900. Used to image the anterior segment of the eye.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
- 2022-09-07FDA-DeviceOculus Optikgeraete GMBHClass IIPentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
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