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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 121–140 of 1,000 recalls

Class IITerminated

The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.

Randox Laboratories Ltd.

***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg

August 1, 2022 · DeviceView details →
Class IITerminated

ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

GELITA MEDICAL GMBH

In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

July 27, 2022 · Device
View details →
Class IITerminated

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

Isopure Corp

Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching

July 26, 2022 · DeviceView details →
Class IITerminated

Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.

Unomedical A/S

The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.

July 21, 2022 · DeviceView details →
Class IITerminated

EVIS EXERA III Bronchovideoscope

Aizu Olympus Co., Ltd.

The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.

July 20, 2022 · DeviceView details →
Class IITerminated

Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

Myolyn Inc.

Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.

July 19, 2022 · DeviceView details →
Class IITerminated

DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.

DeRoyal Industries Inc

The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

July 15, 2022 · DeviceView details →
Class IITerminated

Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

Aesculap Implant Systems LLC

Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:

July 14, 2022 · DeviceView details →
Class IITerminated

TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.

Corin Ltd

Some of the devices did not pass fatigue testing.

July 12, 2022 · DeviceView details →
Class IITerminated

Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708

Trinity Sterile, Inc.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

June 29, 2022 · DeviceView details →
Class IITerminated

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Trinity Sterile, Inc.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

June 29, 2022 · DeviceView details →
Class IITerminated

Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

Trinity Sterile, Inc.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

June 29, 2022 · DeviceView details →
Class IITerminated

SX-One MicroKnife

SONEX HEALTH LLC

Potential of dull blade

June 29, 2022 · DeviceView details →
Class IITerminated

Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF

Trinity Sterile, Inc.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

June 29, 2022 · DeviceView details →
Class IITerminated

(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.

Smith & Nephew, Inc.

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

June 27, 2022 · DeviceView details →
Class IITerminated

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

LumiraDx

Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.

June 24, 2022 · DeviceView details →
Class IITerminated

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

LumiraDx

Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.

June 24, 2022 · DeviceView details →
Class IITerminated

Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

Randox Laboratories Ltd.

Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.

June 22, 2022 · DeviceView details →
Class IITerminated

nordicBrainEX, software versions 2.21 through 2.3.10

NordicNeuroLab AS

When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.

June 16, 2022 · DeviceView details →
Class IITerminated

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.

Stryker Instruments Div. of Stryker Corporation

When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.

June 15, 2022 · DeviceView details →
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