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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 921–940 of 1,000 recalls

Class IITerminated

FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

Ostial Corporation

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.

July 14, 2021 · DeviceView details →

Class IIITerminated

Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

Stanbio Laboratory, LP

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

July 12, 2021 · DeviceView details →

Class IIITerminated

Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.

Stanbio Laboratory, LP

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

July 12, 2021 · DeviceView details →

Class IITerminated

ACUSON Juniper Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.

July 12, 2021 · DeviceView details →

Class IIITerminated

Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

Stanbio Laboratory, LP

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

July 12, 2021 · DeviceView details →

Class IIITerminated

Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.

Stanbio Laboratory, LP

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

July 12, 2021 · DeviceView details →

Class IIITerminated

Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.

Stanbio Laboratory, LP

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

July 12, 2021 · DeviceView details →

Class IITerminated

Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US

Edwards Lifesciences, LLC

There is a potential for internal leaks within catheters.

July 9, 2021 · DeviceView details →

Class IITerminated

Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US

Edwards Lifesciences, LLC

There is a potential for internal leaks within catheters.

July 9, 2021 · DeviceView details →

Class IITerminated

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563

Edwards Lifesciences, LLC

There is a potential for internal leaks within catheters.

July 9, 2021 · DeviceView details →

Class IITerminated

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532

Edwards Lifesciences, LLC

There is a potential for internal leaks within catheters.

July 9, 2021 · DeviceView details →

Class IITerminated

COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm; REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm; REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed; REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm; REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm; REF: 519C/519C.BX, Regular Sterile, Molded break point 100 mm; REF: 220250 P/N: 519CS01.BD, Regular, Sterile Single wrapped Molded bp 100mm; REF: 525CS01, Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm; REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube REF: 534CS01, Flexible Nylon, Sterile Single Wrapped; REF: 551C, Minitip Sterile in dry tube, Molded Break Point 80 mm; REF: 552C/552C.BX, Regular sterile in dry tube Molded Break Point 80 mm; REF: 553C, Flexible sterile in dry tube, molded bp 100 mm; REF: 553C.LC, Flexible Sterile in dry tube, molded bp 100 mm; REF: 5U002S, Regular, sterile, in tube, 80 mm breakpoint, with low stopper; 5U048N01.BIO, REF: 5U055S02.HG, Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch; REF: 5U056S.IUO, FLOQSwats ADULT IN DRY TUBE, Investigational Use Only; REF: 5UO57S.IUO, FLOQSwabs CHILD IN DRY TUBE, Investigational Use Only

Copan Italia

A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.

July 9, 2021 · DeviceView details →

Class IITerminated

Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556

Edwards Lifesciences, LLC

There is a potential for internal leaks within catheters.

July 9, 2021 · DeviceView details →

Class IITerminated

Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US

Edwards Lifesciences, LLC

There is a potential for internal leaks within catheters.

July 9, 2021 · DeviceView details →

Class IITerminated

The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterile

Vascutek, Ltd.

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

July 8, 2021 · DeviceView details →

Class IITerminated

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

Sunrise Medical (US) LLC

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

July 8, 2021 · DeviceView details →

Class IITerminated

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

Vascutek, Ltd.

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

July 8, 2021 · DeviceView details →

Class IITerminated

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

Sunrise Medical (US) LLC

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

July 8, 2021 · DeviceView details →

Class ITerminated

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Baxter Healthcare Corporation

Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.

July 7, 2021 · DeviceView details →

Class IITerminated

Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

Advance Dx, Inc.

Due to high glucose test results when using the blood collection cards.

July 6, 2021 · DeviceView details →

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