Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2419-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2420-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2421-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2422-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2423-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2424-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2425-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2426-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2427-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2428-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2429-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Apr 25, 2023
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Reason: The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Root cause: Software design
Recalling firm: BioFire Diagnostics, LLCType: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemDistribution: US:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
OUS: AD, AE, AI, AR, AT, AU, BD, BE, BF, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GA, GB, GE, GH, GM, GR, GU, HK, HU, IC, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LV, MO, MX, MY, NL, NO, NP, NZ, PG, PH, PL, PT, QA, RS, SA, SE, SG, SI, TH, TN, TR, TW, VN, ZA, ZWRecall #Z-2588-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Aug 10, 2023
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16
Reason: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Root cause: Under Investigation by firm
Recalling firm: ETHICON, LLCType: Suture, Surgical, Absorbable, PolydioxanoneDistribution: US Nationwide. Global Distribution.Recall #Z-2616-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Aug 10, 2023
PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z416H-50, Z421H-50, Z421H-50, Z421H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z422H-50, Z423H-50, Z423H-50, Z423H-50, Z442H-50, Z442H-50, Z442H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z443H-50, Z489G-50, Z489G-50, Z489G-50, Z489G-50, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z493G-50, Z494G-50, Z495G-05, Z495G-05, Z495G-05, Z496G-50, Z496G-50, Z496G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z497G-50, Z503G-50, Z504G-50, Z507G-50, Z507G-50, Z683G-05, Z833G-05, Z833G-05, Z844G-50
Reason: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Root cause: Under Investigation by firm
Recalling firm: ETHICON, LLCType: Suture, Surgical, Absorbable, PolydioxanoneDistribution: US Nationwide. Global Distribution.Recall #Z-2617-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 14, 2023
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Reason: Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance
Root cause: Process control
Recalling firm: Copan Diagnostics IncType: Micro PipetteDistribution: US: CA
OUS: NoneRecall #Z-2620-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Aug 29, 2024
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Reason: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Root cause: Process control
Recalling firm: CooperVision, Inc.Type: Lenses, Soft Contact, Extended WearDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-3310-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Aug 29, 2024
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Reason: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Root cause: Process control
Recalling firm: CooperVision, Inc.Type: Lenses, Soft Contact, Extended WearDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-3311-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Feb 15, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central
monitoring system.
Model: RGD2461AMI
Philips Part # 866126
Reason: If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.
Root cause: Device Design
Recalling firm: Philips North America LlcType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution in the states of CA, IL, ME, NC, NJ, NM, NY, OH, VA, WA and the countries of Australia, Austria, Canada, France, Germany, Italy, Japan,
Netherlands, New Zealand, Portugal, Saudi Arabia, United Kingdom.Recall #Z-3312-2024 Open, ClassifiedPosted Sep 30, 2024·Initiated Aug 8, 2024
DAILIES TOTAL1,
DAILIES TOTAL1 for Astigmatism,
DAILIES TOTAL1 Multifocal,
TOTAL30 Sphere,
Reason: Material with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the entirety of their labeled shelf life, and wearing these lenses may lead to temporary issues such as irritation, redness, or blurred vision.
Root cause: Process change control
Recalling firm: Alcon Research LLCType: Lenses, Soft Contact, Daily WearDistribution: US: UT, TX, NC, MT, AL, WA, MS, PA, LA, MI, GA, FL, KY, OH, AZ, IL, CA, NJ, TN, NY, AR, MN, WI, MD, OK, SC, OR, MA, CO, VA, CT, IA, DE, WV, MO, ID, SD, NE, NV, IN, ME, VT, NM, NH, AK, HI, KS, RI, WY, PR, DC.
OUS: GB, NL, HK, ES, PL, IT, FR, CA, CH, PT, AT, DE, NO, GG, LU, CZ, SK, DK, FI, SE, IN, OM, BE, QA, KW, SA, AE, LB, BH, HU, MY, IE, SG, IS, XI, MK, GI, MT, KR, SI, NZ, GR, GF, GP, MQ, TW, EE, GL, GE, IL, UA, FO, LV, AD, RS, LT, RO, SM, AZ, AU, JE, HR, AX, LI, CY, BGRecall #Z-3313-2024
Open, ClassifiedPosted Sep 27, 2024·Initiated Aug 21, 2024
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Reason: Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Root cause: Device Design
Recalling firm: Percussionaire CorporationType: Set, Tubing And Support, Ventilator (W Harness)Distribution: US: Nationwide
OUS: Israel Japan Russia Switzerland Canada TurkeyRecall #Z-3207-2024