Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) AMB VITRECTOMY, Pack Number DYNJ59921B;
b) AMB VITRECTOMY, Pack Number DYNJ59921BH;
c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B;
d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH;
e) AMB CUSTOM EYE, Pack Number DYNJ59924B;
f) AMB CUSTOM EYE, Pack Number DYNJ59924BH;
g) CATARACT-30843, Pack Number DYNJVB91139
Reason: XXX
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Eye TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3120-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Jun 27, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) LAMINECTOMY CDS, Pack Number CDS981510L;
b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D;
c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F;
d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C;
e) LAMINECTOMY, Pack Number DYNJ908091B;
f) PODIATRY, Pack Number DYNJ908092C;
g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B;
h) CRANI, Pack Number DYNJ908097A;
i) HIP PINNING, Pack Number DYNJ908102B;
j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B;
k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B;
m) HAND-LF, Pack Number DYNJ908425;
n) TOTAL JOINT, Pack Number DYNJ908660A;
o) MERCY TIFFIN HAND, Pack Number DYNJ909734;
p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738;
q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740;
r) ACL-WHSC, Pack Number DYNJ910074A;
s) EXTREMITY-WHSC, Pack Number DYNJ910077;
t) EXTREMITY-WHSC, Pack Number DYNJ910077A;
u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A;
v) MICRODISC, Pack Number DYNJ910370;
w) MTHZ TOTAL HIP, Pack Number DYNJC9311L
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Root cause: Process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.Recall #Z-3121-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Aug 7, 2024
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Reason: Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
Root cause: Under Investigation by firm
Recalling firm: BioFire Diagnostics, LLCType: Instrumentation For Clinical Multiplex Test SystemsDistribution: Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.Recall #Z-3122-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Aug 7, 2024
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
Reason: Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
Root cause: Under Investigation by firm
Recalling firm: BioFire Diagnostics, LLCType: Respiratory Virus Panel Nucleic Acid Assay SystemDistribution: Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.Recall #Z-3123-2024
Open, ClassifiedPosted Sep 11, 2024·Initiated Aug 8, 2024
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
Reason: Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
Root cause: Under Investigation by firm
Recalling firm: Fresenius Medical Care Holdings, Inc.Type: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide. Canada.Recall #Z-3124-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated Mar 1, 2024
25-LHP-828, HeNe Laser System, 35 mW
Reason: These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: PACIFIC LASERTECH, LLCType: General Purpose Laser ProductsDistribution: US Nationwide DistributionRecall #Z-2975-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated Mar 1, 2024
25-LHP-928, HeNe Laser System, 25 mW
Reason: These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: PACIFIC LASERTECH, LLCType: General Purpose Laser ProductsDistribution: US Nationwide DistributionRecall #Z-2976-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated Mar 1, 2024
N-LHP-928, HeNe Laser System, 35 mW
Reason: These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: PACIFIC LASERTECH, LLCType: General Purpose Laser ProductsDistribution: US Nationwide DistributionRecall #Z-2977-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated Jul 8, 2024
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE
Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Reason: Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
Root cause: Under Investigation by firm
Recalling firm: Ion Beam Applications S.A.Type: System, Radiation Therapy, Charged-Particle, MedicalDistribution: Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.Recall #Z-3089-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated May 7, 2024
Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
Reason: Potential for an incomplete seal on the packaging tray.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-3092-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated May 7, 2024
Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
Reason: Potential for an incomplete seal on the packaging tray.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-3093-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated May 7, 2024
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Reason: Potential for an incomplete seal on the packaging tray.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedDistribution: US Nationwide distribution.Recall #Z-3094-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated May 7, 2024
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
Reason: Potential for an incomplete seal on the packaging tray.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Single-Use Reprocessed Ultrasonic Surgical InstrumentsDistribution: US Nationwide distribution.Recall #Z-3095-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated Aug 12, 2024
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues.
Product Number: 2504-1
Reason: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Root cause: Packaging
Recalling firm: Smith & Nephew Inc.Type: Staple, ImplantableDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates/Dubai (UAE).Recall #Z-3096-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated Aug 12, 2024
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.
Product Number: 72205201
Reason: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Root cause: Packaging
Recalling firm: Smith & Nephew Inc.Type: Staple, ImplantableDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates/Dubai (UAE).Recall #Z-3097-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated Aug 13, 2024
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Reason: This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
Root cause: Labeling design
Recalling firm: Zoe Medical IncorporatedType: OximeterDistribution: awaiting additional detailsRecall #Z-3098-2024
Open, ClassifiedPosted Sep 10, 2024·Initiated Aug 13, 2024
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Reason: This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
Root cause: Labeling design
Recalling firm: Zoe Medical IncorporatedType: OximeterDistribution: awaiting additional detailsRecall #Z-3099-2024
Open, ClassifiedPosted Sep 7, 2024·Initiated Aug 7, 2024
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Reason: Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
Root cause: Component design/selection
Recalling firm: B Braun Medical IncType: Pump, InfusionDistribution: US distribution to AL, CA, GA, IL, MI, and TX.Recall #Z-2972-2024 Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits, labeled as:
1) TRACHEOTOMY TRAY, Pack Number DYNDA1894;
2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Catheters, Suction, TracheobronchialDistribution: Worldwide distribution.Recall #Z-2981-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Apr 8, 2024
Medline Convenience kits, labeled as:
1) TRACH CDS-LF , Pack Number CDS983142B ;
2) MER TRACH CDS , Pack Number CDS984376B ;
3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P;
4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DYND300015P;
5) Flexible LMA Pack with Syringe and Lube, Size 2, Pack Number DYND300020P;
6) Flexible LMA Pack with Syringe and Lube, Size 2.5, Pack Number DYND300025P;
7) Flexible LMA Pack with Syringe and Lube, Size 3, Pack Number DYND300030P;
8) Flexible LMA Pack with Syringe and Lube, Size 4, Pack Number DYND300040P;
9) Flexible LMA Pack with Syringe and Lube, Size 5, Pack Number DYND300050P;
10) TRACHEOSTOMY TRAY , Pack Number DYNDJ1061A ;
11) TRACHEOSTOMY , Pack Number DYNJ45495F
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Airway, Oropharyngeal, AnesthesiologyDistribution: Worldwide distribution.Recall #Z-2982-2024