🏥

Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 00585205009 00585205010 00585205011 00585205012 00585205013 00585205014 00585205015 00585205016 00585205017 00585205018 00585205019 00585205209 00585205210 00585205211 00585205212 00585205213 00585205214 00585205215 00585205216 00585205217 00585205218 00585205219 00585205412 00585205413 00585205414 00585205415 00585205416 00585205417 00585205418 00585205419 00585207009 00585207010 00585207011 00585207012 00585207013 00585207014 00585207015 00585207016 00585207017 00585207018 00585207019 00585207409 00585207410 00585207411 00585207412 00585207413 00585207414 00585207415 00585207416 00585207417 00585207418 00585207419 500000001 500000005 500000010 500010000 502000001 502006006 502006011

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905

Thermo Fisher Scientific (Monterrey)

Class I - Dangerous

Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

Jul 18, 2019 Infusion Pumps View Details →

Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

GE Healthcare

Class I - Dangerous

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

Jul 26, 2019 Other Medical Devices Nationwide View Details →

FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Infusion Pumps Nationwide View Details →

Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Western / Scott Fetzer Company

Class I - Dangerous

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Aug 15, 2019 Diagnostic Equipment Nationwide View Details →

Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Argon Medical Devices

Class I - Dangerous

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Oct 16, 2018 Other Medical Devices Nationwide View Details →

CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Implants & Prosthetics Nationwide View Details →

Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Argon Medical Devices

Class I - Dangerous

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Oct 16, 2018 Other Medical Devices Nationwide View Details →

Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

MEDTECH SAS

Class I - Dangerous

The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.

Sep 10, 2019 Implants & Prosthetics Nationwide View Details →

CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.

Becton Dickinson & Company

Class I - Dangerous

A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.

Sep 16, 2019 Diagnostic Equipment View Details →

Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904

Thermo Fisher Scientific (Monterrey)

Class I - Dangerous

Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

Jul 18, 2019 Other Medical Devices View Details →

VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

Ortho-Clinical Diagnostics

Class I - Dangerous

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

Sep 10, 2019 Other Medical Devices Nationwide View Details →

Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Western / Scott Fetzer Company

Class I - Dangerous

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Aug 15, 2019 Diagnostic Equipment Nationwide View Details →

Petfine Auto Injector, REF 3310VET

Owen Mumford USA

Class I - Dangerous

There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107

Jul 17, 2019 Other Medical Devices View Details →

SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

Helena Laboratories

Class I - Dangerous

Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.

Feb 27, 2018 Other Medical Devices Nationwide View Details →

Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.

Philips Medical Systems (Cleveland)

Class I - Dangerous

An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

Sep 19, 2019 Other Medical Devices Nationwide View Details →