Medical Device Recalls

7,959 medical device recalls from federal enforcement feeds.

Showing 3,601–3,650 of 7,959

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

  Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

  Class II

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  Tornier S.A.S.

  stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty

  Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

  Class II

• Medical Device Recall · March 5, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R

  Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

  Class II

• Medical Device Recall · March 5, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R

  Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

  Class II

• Medical Device Recall · March 4, 2025

  Medtronic MiniMed, Inc.

  InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

  Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

  Class II

• Medical Device Recall · March 4, 2025

  Abbott Diagnostics Scarborough, Inc.

  Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

  the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

  Class II

• Medical Device Recall · March 4, 2025

  Abbott Diagnostics Scarborough, Inc.

  Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

  The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

  Class II

• Medical Device Recall · March 4, 2025

  Abbott Diagnostics Scarborough, Inc.

  Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic A

  The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

  Class II

• Medical Device Recall · March 4, 2025

  Cordis US Corp

  Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

  product mix-up; Vascular stent labeled as one size but contains a different size.

  Class II

• Medical Device Recall · March 4, 2025

  Medtronic Neuromodulation

  Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators

  There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

  Class II

• Medical Device Recall · March 4, 2025

  Cordis US Corp

  Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only

  product mix-up; Vascular stent labeled as one size but contains a different size.

  Class II

• Medical Device Recall · March 4, 2025

  Abbott Diagnostics Scarborough, Inc.

  Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic A

  the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

  Class II

• Medical Device Recall · March 4, 2025

  Abbott Diagnostics Scarborough, Inc.

  Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle

  The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

  Class II

• Medical Device Recall · March 4, 2025

  Abbott Diagnostics Scarborough, Inc.

  Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle

  the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

  Class II

• Medical Device Recall · March 4, 2025

  ZOLL Circulation, Inc.

  Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Descript

  AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

  Class I

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, M

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Numb

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT,

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270

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

  Class II

• Medical Device Recall · March 3, 2025

  ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY

  Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

  Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  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)

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  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

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  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:

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

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

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DY

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ3

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  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

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Refer to RES

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

  Class II

• Medical Device Recall · March 3, 2025

  Tornier, Inc

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

  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)

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  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 Nu

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

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

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

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

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

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

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Refer to RES

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTA

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ

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

  Class II

• Medical Device Recall · March 3, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50

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

  Class II