Other Medical Devices Recalls

RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0

RAYSEARCH LABORATORIES AB

Class I - Dangerous

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

Jul 17, 2023 Other Medical Devices Nationwide View Details →

Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.

Olympus Corporation of the Americas

Class I - Dangerous

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Jul 27, 2023 Other Medical Devices Nationwide View Details →

PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

Smiths Medical ASD

Class I - Dangerous

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

Jul 18, 2023 Other Medical Devices Nationwide View Details →

The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5

Olympus Corporation of the Americas

Class I - Dangerous

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m)¿¿¿ B13111027, n)¿¿¿¿ B13111034, o)¿¿¿¿ B13111035, p)¿¿¿¿ B13111036; intervertebral fusion device - cervical

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail

Smith & Nephew

Class I - Dangerous

A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

Jul 24, 2023 Other Medical Devices View Details →

IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q) B247C08062810, r) B247C08063210, s) B247C09062410, t) B247C09062810, u) B247C09063210, v) B247C10062410, w) B247C10062810, x) B247C10063210, y) B247C11062410, z) B247C11062810, aa) B247C11063210, bb) B247C12062410, cc) B247C12062810, dd) B247C12063210, ee) B247C13062410, ff) B247C13062810, gg) B247C13063210, hh) B247C14062410, ii) B247C14062810, jj) B247C14063210, kk) B247C15062810, ll) B247C15063210; intervertebral fusion device - lumbar

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail

Smith & Nephew

Class I - Dangerous

A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

Jul 24, 2023 Other Medical Devices View Details →

IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR

Invacare

Class I - Dangerous

Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user

Jun 15, 2023 Other Medical Devices Nationwide View Details →

PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar

Medicrea International

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

Centurion FMS Pak

Alcon Research

Class I - Dangerous

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

Legion FMS Pak

Alcon Research

Class I - Dangerous

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Jun 28, 2023 Other Medical Devices Nationwide View Details →