Medical Device Recalls

8,689 medical device recalls from federal enforcement feeds.

Showing 4,351–4,400 of 8,689

• 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

  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

  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

  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) 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) 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) 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

  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) 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) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Numbe

  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) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339

  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) 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) 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) 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) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239

  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) 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

  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) 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) 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) 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) 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) 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) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, 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) 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

  Baxter Healthcare Corporation

  Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS

  Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

  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) 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 · February 28, 2025

  Stryker Spine

  Monterey AL Implant Inserter; 22mm; Catalog 48019140.

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

  Class II

• Medical Device Recall · February 28, 2025

  Reichert, Inc.

  Phoroptor VRx Digital Refraction System Model Numbers: 16242

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

  Class II

• Medical Device Recall · February 28, 2025

  Reichert, Inc.

  Phoroptor VRx Digital Refraction System Model Numbers: 16241

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

  Class II

• Medical Device Recall · February 28, 2025

  Stryker Spine

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

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

  Class II

• Medical Device Recall · February 28, 2025

  Stryker Spine

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

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

  Class II

• Medical Device Recall · February 28, 2025

  Philips Medical Systems Nederland B.V.

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

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

  Class II

• Medical Device Recall · February 28, 2025

  Stryker Spine

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

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

  Class II

• Medical Device Recall · February 27, 2025

  Zimmer, Inc.

  NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

  The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

  Class II

• Medical Device Recall · February 27, 2025

  Tandem Diabetes Care, Inc.

  t:slim X2 Insulin Pump with Interoperable Technology

  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.

  Class I

• Medical Device Recall · February 27, 2025

  Premier Dental Products Co

  Premier Solo Diamond - Large Invented Cone; SKU: 807016C.

  The hardness not meeting the material specification and may cause the diamond bur to bend.

  Class II

• Medical Device Recall · February 27, 2025

  Tandem Diabetes Care, Inc.

  Tandem Mobi Insulin Pump with Interoperable Technology

  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.

  Class I

• Medical Device Recall · February 27, 2025

  CooperVision, Inc.

  Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voy

  a limited number of lots were manufactured with an incorrect cylinder power.

  Class II

• Medical Device Recall · February 27, 2025

  BioFire Diagnostics, LLC

  FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

  Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

  Class II

• Medical Device Recall · February 27, 2025

  Beckman Coulter, Inc.

  Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

  Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.

  Class II

• Medical Device Recall · February 26, 2025

  Qapel Medical Inc.

  Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration

  Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.

  Class I

• Medical Device Recall · February 26, 2025

  Beckman Coulter Inc.

  DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemi

  Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.

  Class II

• Medical Device Recall · February 26, 2025

  Intuitive Surgical, Inc.

  Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A

  Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

  Class II

• Medical Device Recall · February 26, 2025

  Covidien

  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

  Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

  Class I

• Medical Device Recall · February 25, 2025

  Baxter Healthcare Corporation

  Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204

  There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

  Class II

• Medical Device Recall · February 25, 2025

  Baxter Healthcare Corporation

  Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

  There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

  Class II