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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 3761–3780 of 39,430 recalls

Class IIOngoing

Refer to RES

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented

Tornier, Inc

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PERI GYN, Model Number: DYNJ67708A; 6) HYSTEROSCOPY PACK, Model Number: DYNJ56417C; 7) HYSTEROSCOPY PACK CKHA-LF, Model Number: DYNJ51956B; 8) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040; 6) D&C, Model Number: DYNJ900422F; 7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A; 8) D AND C PACK, Model Number: DYNJ66290A; 9) D&C PACK, Model Number: DYNJ47616B; 10) WMC D & C PACK-LF, Model Number: DYNJ50656B; 11) TRANSVAGINAL PACK, Model Number: DYNJ36599; 12) OB PACK, Model Number: DYNJ25915G; 13) PERI GYN-LF, Model Number: DYNJS3040; 14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A; 15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A; 16) OB PACK, Model Number: DYNJ64571; 17) WMC D & C PACK-LF, Model Number: DYNJ50656B; 18) D & C PACK-LF, Model Number: DYNJT2535G; 19) OB PACK, Model Number: DYNJ44522B; 20) OB PACK-LF, Model Number: DYNJ26121G; 21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Refer to RES

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH PACK, Model Number: DYNJ51338C; 6) BRISTOL MYELOGRAM, Model Number: DYNDH1228; 7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A; 8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 9) CATH LAB PACK, Model Number: DYNJ85070; 10) CT SCAN PACK, Model Number: DYNJ39515A; 11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ; 12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D; 13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974; 14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A; 15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020; 16) PORTACATH PACK, Model Number: DYNJ51240A; 17) RADIOLOGY PACK, Model Number: DYNJ43969; 18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I; 19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number: DYNJ85284; 6) PHACO PACK, Model Number: DYNJ44748I; 7) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 8) CHOG MINOR OPHTHALMIC PACK, Model Number: SYNJ10271B; 9) LIFESPAN VITRECTOMY PACK, Model Number: DYNJ80082; 10) DR KEYS EYE PACK 2, Model Number: DYNJ48256M; 11) VITRECTOMY PACK, Model Number: DYNJ55508B; 12) EYE PACK, Model Number: DYNJ63952A; 13) VITRECTOMY, Model Number: DYNJ67309C; 14) CATARACT PACK-MARY IMMACUL-LF, Model Number: DYNJ24516F; 15) DR FLOOD EYE PACK, Model Number: DYNJ57258G; 16) BLEPH PACK, Model Number: DYNJ67875; 17) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) OPHTHALMOLOGY PACK, Model Number: SYNJ10259A; 20) PLASTIC EYE, Model Number: DYNJ45667C; 21) BASIC EYE PACK, Model Number: DYNJ81548B; 22) WMC CATARACT PACK-LF, Model Number: DYNJ50653F; 23) BASIC CATARACT, Model Number: DYNJ41097A; 24) PK EYE, Model Number: DYNJ60631B; 25) EYE PLASTIC SURGERY PACK, Model Number: DYNJ44061; 26) CATARACT, Model Number: DYNJ44544F; 27) CATARACT PACK, Model Number: DYNJ49515D; 28) CATARACT PACK, Model Number: DYNJ35438F; 29) OPHTHALMIC PLASTIC PACK, Model Number: DYNJ55208A; 30) CATARACT PACK, Model Number: DYNJ81534B; 31) CATARACT PACK, Model Number: DYNJ49515D

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK, Model Number: DYNJ65027B; 7) VASCULAR PACK-LF, Model Number: DYNJ48196C; 8) IMPLANT PACK, Model Number: DYNJ40480; 9) OPEN HEART, Model Number: DYNJ900523B; 10) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 11) CHOG VP SHUNT PACK, Model Number: SYNJ10280C; 12) VASCULAR PACK-LF, Model Number: DYNJ48196C; 13) EP PACK-LF, Model Number: DYNJ27949F; 14) PACEMAKER PACK WRO-LF, Model Number: DYNJ41874C; 15) CARDIAC PACK OPTION 1, Model Number: DYNJ83208A; 16) EP DRAPE PACK, Model Number: DYNJ56729; 17) CSTM EP PACEMAKER DRAPE PACK, Model Number: DYNJCD0326; 18) MINOR INTERVENTIONAL TRAY, Model Number: DYNJ80084; 19) CT PACK, Model Number: DYNJ39111A; 20) VASCULAR PACK-LF, Model Number: DYNJ25102I; 21) VASCULAR ACCESS PROCEDURE PACK, Model Number: DYNJ62339; 22) ANGIO TRAY, Model Number: DYNJ43278C; 23) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 24) E.P. BASIC PACK-LF, Model Number: DYNJ24735F; 25) PORT A CATH PACEMAKER BJC-LF, Model Number: DYNJ41683B; 26) PACEMAKER PACK, Model Number: DYNJ39379C; 27) VEIN PACK, Model Number: DYNJ64016B; 28) EP PACK, Model Number: DYNJ68019A; 29) ENDOVENOUS BASIC PACK, Model Number: DYNJ69108A; 30) PACEMAKER PACK-LF, Model Number: DYNJHTCLP101A; 31) EP PACK, Model Number: DYNJ38147C; 32) HEART PRCMNT CHOICE, Model Number: DYNDA1841; 33) PACEMAKER PACK SMGH-LF, Model Number: DYNJ41925I; 34) EP PACK, Model Number: DYNJ81951B; 35) HEALTH ALL VASCULAR PACK-LF, Model Number: DYNJ19538F; 36) OPEN HEART, Model Number: CDS982026V; 37) OPEN HEART, Model Number: CDS982026V

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.

Stryker Spine

Potential for the gold unlock button to separate from the inserter.

February 28, 2025 · DeviceView details →

Class IIOngoing

Phoroptor VRx Digital Refraction System Model Numbers: 16241

Reichert, Inc.

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

February 28, 2025 · DeviceView details →

Class IIOngoing

Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;

Philips Medical Systems Nederland B.V.

Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

February 28, 2025 · DeviceView details →

Class IIOngoing

Phoroptor VRx Digital Refraction System Model Numbers: 16242

Reichert, Inc.

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

February 28, 2025 · DeviceView details →

Class IIOngoing

Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.

Stryker Spine

Potential for the gold unlock button to separate from the inserter.

February 28, 2025 · DeviceView details →

Class IIOngoing

Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.

Stryker Spine

Potential for the gold unlock button to separate from the inserter.

February 28, 2025 · DeviceView details →

Class IIOngoing

Monterey AL Implant Inserter; 22mm; Catalog 48019140.

Stryker Spine

Potential for the gold unlock button to separate from the inserter.

February 28, 2025 · DeviceView details →

t:slim X2 Insulin Pump with Interoperable Technology

Tandem Diabetes Care, Inc.

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

February 27, 2025 · DeviceView details →

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