CLASS I Device recall · Reported 14 Nov 2018 · FDA Enforcement Report
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F recalled by Oscor
Oscor is recalling TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, distributed nationwide in the US. The recall was initiated on 26 Sep 2018 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0391-2019
- FDA event ID
- 80984
- Recalling firm
- Oscor, Palm Harbor, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Sep 2018
- FDA classified
- 8 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 26 Sep 2018 | Recall initiated by company | |
| 8 Nov 2018 | Classified by FDA | +43 days |
| 14 Nov 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, HI, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PR, RI, TN, TX, UT, VA, WA. Countries of AUSTRIA, BENIN REPUBLIC, BOLIVIA, BRAZIL, BULGARIA, CANADA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GEORGIA, GERMANY, GREECE, GUATEMALA, INDIA, IRAN, IRAN, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, MACEDONIA, MAURITIUS, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SENEGAL, SOUTH AFRICA, TAIWAN, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouriNorth CarolinaNebraskaNew JerseyNew MexicoNevada
Questions about this recall
Is TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J recalled?
Yes. Oscor recalled TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J on 26 Sep 2018. The recall is Class I and its status is Terminated. Recall number Z-0391-2019.
Why was it recalled?
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
Which lots are affected?
Item Number (Lot Number): a. TB Lead, 4F Un-Shrouded, Model Number 020004 - 2B-81-532Z-D (OR-03868), 2B-81-532Z-D (OR-03874), 2B-81-532Z-D (C1-06951), 2B-81-532Z-D (C1-06993), 2B-81-532Z-D (C1-06994), 2B-81-532Z-D (C1-07016), 2B-81-532Z-D (C1-07018), 2B-81-532Z-D (C1-07017), 2B-81-532Z-D (D1-02633), 2B-81-532Z-D (D1-02883), 2B-81-532Z-D (DP-01395), 2B-81-532Z-D (OR-04404), 2B-81-532Z-D (C1-09074), 2B-81-532Z-D (C1-09166), 2B-81-532Z-D (DP-02801), 2B-81-532Z-D (DP 02801), 2B-81-532Z-D (DP-04451), 2B-81-532Z-D (DP-05052), 2B-81-532Z-D (DP-05115), 2B-81-532Z-D (DP-05225), 2B-81-532Z-D (DP-05371), 2B-81-532Z-D (DP-05482), 2B-81-532Z-D (DP-05516), 2B-81-532Z-D (DP-05938), 2B-81-532Z-D (DP05968), 2B-81-532Z-D (DP-05976), 2B-81-532Z-D (DP-05998), 2B-81-532Z-D (DP-06062), 2B-81-532Z-D (DP-06098), 2B-81-532Z-D (DP-06203), 2B-81-532Z-D (DP-07789), 2B-81-532Z-D (DP-07840), 2B-81-532Z-D (DP-08130); b. TB LEAD, 5F UN-SHROUDED, Model Number 020005 - 2B-81-532Z-E (D2-01795), 2B-81-532Z-E (C1-06923), 2B-81-532Z-E (C1-06946), 2B-81-532Z-E (C1-06947), 2B-81-532Z-E (C1-06945), 2B-81-532Z-E (C1-06997), 2B-81-532Z-E (C1-06995), 2B-81-532Z-E (C1-06996), 2B-81-532Z-E (C1-07013), 2B-81-532Z-E (C1-07015), 2B-81-532Z-E (C1-07012), 2B-81-532Z-E (C1-07014), 2B-81-532Z-E (D2-01939), 2B-81-532Z-E (D1-02542), 2B-81-532Z-E (D1-02805), 2B-81-532Z-E (DP-01259), 2B-81-532Z-E (DP-01455), 2B-81-532Z-E (DP-01554), 2B-81-532Z-E (OR-04380), 2B-81-532Z-E (C1-08496), 2B-81-532Z-E (C1-08486), 2B-81-532Z-E (C1-08497), 2B-81-532Z-E (C1-08495), 2B-81-532Z-E (OR-04407), 2B-81-532Z-E (C1-08487), 2B-81-532Z-E (C1-08488), 2B-81-532Z-E (C1-08499), 2B-81-532Z-E (C1-08494), 2B-81-532Z-E (C1-08498), 2B-81-532Z-E (C1-08678), 2B-81-532Z-E (C1-08676), 2B-81-532Z-E (C1-08677), 2B-81-532Z-E (C1-08686), 2B-81-532Z-E (C1-08687), 2B-81-532Z-E (C1-08688), 2B-81-532Z-E (C1-08689), 2B-81-532Z-E (C1-08691), 2B-81-532Z-E (C1-08685), 2B-81-532Z-E (C1-08679), 2B-81-532Z-E (C1-08693), 2B-81-532Z-E (C1-08694), 2B-81-532Z-E (DP-02161), 2B-81-532Z-E (C1-08692), 2B-81-532Z-E (C1-09046), 2B-81-532Z-E (C1-09047), 2B-81-532Z-E (C1-09048), 2B-81-532Z-E (C1-09251), 2B-81-532Z-E (C1-09252), 2B-81-532Z-E (C1-09253), 2B-81-532Z-E (DP-02766), 2B-81-532Z-E (DP-02790), 2B-81-532Z-E (DP-02844), 2B-81-532Z-E (DP-03289), 2B-81-532Z-E (DP-03247), 2B-81-532Z-E (DP-03424), 2B-81-532Z-E (DP-04422), 2B-81-532Z-E (DP-04455), 2B-81-532Z-E (DP-04504), 2B-81-532Z-E (DP-04772), 2B-81-532Z-E (DP-04815), 2B-81-532Z-E (DP-04817), 2B-81-532Z-E (DP-04957), 2B-81-532Z-E (DP-05027), 2B-81-532Z-E (DP-05044), 2B-81-532Z-E (DP-05045), 2B-81-532Z-E (DP-05116), 2B-81-532Z-E (DP-05045_1), 2B-81-532Z-E (DP 05116), 2B-81-532Z-E (DP-05274), 2B-81-532Z-E (DP-05417), 2B-81-532Z-E (DP-05543), 2B-81-532Z-E (DP-05686), 2B-81-532Z-E (DP-05687), 2B-81-532Z-E (DP-05958), 2B-81-532Z-E (DP-06080), 2B-81-532Z-E (DP-06060), 2B-81-532Z-E (DP-06141), 2B-81-532Z-E (DP-06206), 2B-81-532Z-E (DP-06346), 2B-81-532Z-E (DP-06535), 2B-81-532Z-E (DP-06762), 2B-81-532Z-E (DP-06568), 2B-81-532Z-E (DP-07015), 2B-81-532Z-E (DP-07018), 2B-81-532Z-E (DP-07017), 2B-81-532Z-E (DP-07146), 2B-81-532Z-E (DP-07262), 2B-81-532Z-E (DP-07438), 2B-81-532Z-E (DP-07500), 2B-81-532Z-E (DP-07642), 2B-81-532Z-E (DP-07787), 2B-81-532Z-E (DP-07643); c. TB LEAD, 6F UN-SHROUDED, 020006 - 2B-81-532Z-F (D2-01775), 2B-81-532Z-F (D2-01691), 2B-81-532Z-F (OR-03853), 2B-81-532Z-F (OR-03961), 2B-81-532Z-F (OR-03878), 2B-81-532Z-F (OR-03939), 2B-81-532Z-F (C1-06953), 2B-81-532Z-F (C1-06954), 2B-81-532Z-F (C1-06955), 2B-81-532Z-F (C1-06956), 2B-81-532Z-F (OR-04060), 2B-81-532Z-F (D1-02562), 2B-81-532Z-F (OR-04100), 2B-81-532Z-F (C1-07081), 2B-81-532Z-F (C1-07082), 2B-81-532Z-F (C1-07079), 2B-81-532Z-F (C1-07080), 2B-81-532Z-F (D1-02806), 2B-81-532Z-F (DP-01003), 2B-81-532Z-F (DP-01004), 2B-81-532Z-F (DP-01214), 2B-81-532Z-F (C1-07955), 2B-81-532Z-F (DP-01082), 2B-81-532Z-F (C1-07945), 2B-81-532Z-F (C1-07946), 2B-81-532Z-F (C1-07958), 2B-81-532Z-F (C1-07964), 2B-81-532Z-F (C1-07956), 2B-81-532Z-F (OR-04278), 2B-81-532Z-F (C1-07966), 2B-81-532Z-F (DP-01569), 2B-81-532Z-F (C1-07957), 2B-81-532Z-F (C1-07959), 2B-81-532Z-F (C1-07960), 2B-81-532Z-F (C1-07961), 2B-81-532Z-F (C1-07962), 2B-81-532Z-F (C1-07963), 2B-81-532Z-F (C1-07965), 2B-81-532Z-F (DP-01374), 2B-81-532Z-F (DP-01492), 2B-81-532Z-F (DP-01553), 2B-81-532Z-F (OR-04329), 2B-81-532Z-F (OR-04330), 2B-81-532Z-F (DP-01601), 2B-81-532Z-F (C1-08396), 2B-81-532Z-F (C1-08407), 2B-81-532Z-F (C1-08410), 2B-81-532Z-F (C1-08409), 2B-81-532Z-F (C1-08411), 2B-81-532Z-F (C1-08412), 2B-81-532Z-F (OR-04367), 2B-81-532Z-F (C1-08398), 2B-81-532Z-F (OR-04408), 2B-81-532Z-F (OR-04369), 2B-81-532Z-F (OR-04399), 2B-81-532Z-F (OR-04368), 2B-81-532Z-F (OR-04366), 2B-81-532Z-F (C1-08670), 2B-81-532Z-F (C1-08666), 2B-81-532Z-F (C1-08667), 2B-81-532Z-F (C1-08668), 2B-81-532Z-F (C1-08669), 2B-81-532Z-F (C1-08674), 2B-81-532Z-F (C1-08675), 2B-81-532Z-F (C1-08704), 2B-81-532Z-F (C1-08705), 2B-81-532Z-F (C1-08706), 2B-81-532Z-F (C1-08711), 2B-81-532Z-F (C1-08718), 2B-81-532Z-F (C1-08720), 2B-81-532Z-F (C1-08709), 2B-81-532Z-F (C1-08735), 2B-81-532Z-F (C1-08732), 2B-81-532Z-F (C1-08710), 2B-81-532Z-F (C1-08714), 2B-81-532Z-F (C1-08717), 2B-81-532Z-F (C1-08716), 2B-81-532Z-F (C1-08721), 2B-81-532Z-F (C1-08719), 2B-81-532Z-F (C1-08703), 2B-81-532Z-F (C1-08707), 2B-81-532Z-F (C1-08708), 2B-81-532Z-F (C1-08733), 2B-81-532Z-F (C1-08734), 2B-81-532Z-F (C1-08731), 2B-81-532Z-F (C1-08715), 2B-81-532Z-F (C1-08671), 2B-81-532Z-F (C1-08713), 2B-81-532Z-F (C1-08680), 2B-81-532Z-F (C1-08755), 2B-81-532Z-F (C1-08681), 2B-81-532Z-F (C1-08683), 2B-81-532Z-F (C1-08701), 2B-81-532Z-F (C1-08723), 2B-81-532Z-F (C1-08672), 2B-81-532Z-F (C1-08673), 2B-81-532Z-F (C1-08682), 2B-81-532Z-F (C1-08702), 2B-81-532Z-F (C1-08712), 2B-81-532Z-F (C1-08722), 2B-81-532Z-F (C1-08724), 2B-81-532Z-F (C1-08753), 2B-81-532Z-F (C1-08754), 2B-81-532Z-F (C1-08756), 2B-81-532Z-F (C1-08757), 2B-81-532Z-F (C1-08759), 2B-81-532Z-F (C1-08760), 2B-81-532Z-F (C1-08761), 2B-81-532Z-F (C1-08762), 2B-81-532Z-F (C1-08763), 2B-81-532Z-F (C1-08758), 2B-81-532Z-F (DP-02162), 2B-81-532Z-F (DP-02793), 2B-81-532Z-F (DP-02932), 2B-81-532Z-F (DP-02942), 2B-81-532Z-F (C1-09444), 2B-81-532Z-F (DP-03114), 2B-81-532Z-F (DP-03116), 2B-81-532Z-F (DP-03117), 2B-81-532Z-F (DP-03118), 2B-81-532Z-F (DP-03115), 2B-81-532Z-F (DP-03144), 2B-81-532Z-F (DP-03123), 2B-81-532Z-F (DP-03229), 2B-81-532Z-F (DP-03323), 2B-81-532Z-F (OR-04667), 2B-81-532Z-F (DP-03893), 2B-81-532Z-F (DP-03930), 2B-81-532Z-F (DP-04378), 2B-81-532Z-F (DP-04377), 2B-81-532Z-F (DP-04386), 2B-81-532Z-F (DP-04454), 2B-81-532Z-F (DP-04456), 2B-81-532Z-F (DP-04707), 2B-81-532Z-F (DP-04760), 2B-81-532Z-F (DP-04818), 2B-81-532Z-F (DP-05108), 2B-81-532Z-F (DP-05362), 2B-81-532Z-F (DP-05349), 2B-81-532Z-F (DP-05350), 2B-81-532Z-F (DP-05416), 2B-81-532Z-F (DP-05510), 2B-81-532Z-F (DP-05544), 2B-81-532Z-F (DP-05559), 2B-81-532Z-F (DP-05511), 2B-81-532Z-F (DP-05599), 2B-81-532Z-F (DP-05630), 2B-81-532Z-F (DP-05637), 2B-81-532Z-F (DP-05685), 2B-81-532Z-F (DP-06005), 2B-81-532Z-F (DP-06052), 2B-81-532Z-F (DP-06388), 2B-81-532Z-F (DP-06495), 2B-81-532Z-F (DP-06496), 2B-81-532Z-F (DP-06497), 2B-81-532Z-F (DP-06498), 2B-81-532Z-F (DP-06500), 2B-81-532Z-F (DP-06546), 2B-81-532Z-F (DP-06501), 2B-81-532Z-F (DP-06567), 2B-81-532Z-F (DP-07049), 2B-81-532Z-F (DP-07134), 2B-81-532Z-F (DP-07513), 2B-81-532Z-F (DP-07784), 2B-81-532Z-F (DP-07785), 2B-81-532Z-F (DP-07790), 2B-81-532Z-F (DP-08166), 2B-81-532Z-F (DP-08167); d. TB LEAD, 4F UN-SHROUDED ATRIAL J-TIP, 020010 - 2B-81-532Z-J (C1-06957), 2B-81-532Z-J (DP-01059), 2B-81-532Z-J (DP-04648); e. TB LEAD, 5F UN-SHROUDED ATRIAL J-TIP, 020011 - 2B-81-532Z-K (C1-06940), 2B-81-532Z-K (D1-02916), 2B-81-532Z-K (D1-02559), 2B-81-532Z-K (OR-04406), 2B-81-532Z-K (DP-04647); f. TB LEAD, 6F UN-SHROUDED ATRIAL J-TIP, 020012 - 2B-81-532Z-L (D1-02565), 2B-81-532Z-L (OR-04370), 2B-81-532Z-L (DP-04649); g. TB LEAD, 4F UN-SHROUDED 60 DEG CURVE, 020016 - 2B-81-532Z-P (C1-06952), 2B-81-532Z-P (DP-01058); h. TB LEAD, 5F UN-SHROUDED 60 DEG CURVE, 020017 - 2B-81-532Z-Q (OR-04416), 2B-81-532Z-Q (DP-03054); i. TB LEAD, 6F UN-SHROUDED 60 DEG CURVE, 020018 - 2B-81-532Z-R (D2-01777), 2B-81-532Z-R (OR-03879), 2B-81-532Z-R (D1-02490), 2B-81-532Z-R (D2-01991), 2B-81-532Z-R (D1-02567), 2B-81-532Z-R (DP-01105), 2B-81-532Z-R (DP-01359), 2B-81-532Z-R (OR-04277), 2B-81-532Z-R (OR-04280), 2B-81-532Z-R (DP-01357), 2B-81-532Z-R (DP-01490), 2B-81-532Z-R (OR-04371), 2B-81-532Z-R (OR-04383), 2B-81-532Z-R (DP-06207); j. TB LEAD, 4F UNSHROUDED RIGHT HEART CURVE, 020022 - 2B-81-532Z-V (DP-02185), 2B-81-532Z-V (DP-03321), 2B-81-532Z-V (DP-04708), 2B-81-532Z-V (DP-04709), 2B-81-532Z-V (DP-05354), 2B-81-532Z-V (DP-05415), 2B-81-532Z-V (DP-05414), 2B-81-532Z-V (DP-06061), 2B-81-532Z-V (DP-06760), 2B-81-532Z-V (DP-07891); k. TB LEAD, 5F UN-SHROUDED RIGHT HEART CURVE, 020023 - 2B-81-532Z-W (D1-02822), 2B-81-532Z-W (D1-02817), 2B-81-532Z-W (D1-02924), 2B-81-532Z-W (D1 02817), 2B-81-532Z-W (C1-08091), 2B-81-532Z-W (C1-08096), 2B-81-532Z-W (C1-08098), 2B-81-532Z-W (C1-08095), 2B-81-532Z-W (C1-08097), 2B-81-532Z-W (C1-08133), 2B-81-532Z-W (C1-08134), 2B-81-532Z-W (DP-01116), 2B-81-532Z-W (C1-08135), 2B-81-532Z-W (C1-08101), 2B-81-532Z-W (C1-08121), 2B-81-532Z-W (C1-08124), 2B-81-532Z-W (C1-08123), 2B-81-532Z-W (C1-08128), 2B-81-532Z-W (C1-08137), 2B-81-532Z-W (C1-08099), 2B-81-532Z-W (C1-08103), 2B-81-532Z-W (C1-08104), 2B-81-532Z-W (C1-08106), 2B-81-532Z-W (C1-08112), 2B-81-532Z-W (C1-08113), 2B-81-532Z-W (C1-08114), 2B-81-532Z-W (C1-08115), 2B-81-532Z-W (C1-08117), 2B-81-532Z-W (C1-08118), 2B-81-532Z-W (C1-08120), 2B-81-532Z-W (C1-08126), 2B-81-532Z-W (C1-08127), 2B-81-532Z-W (C1-08136), 2B-81-532Z-W (C1-08092), 2B-81-532Z-W (C1-08100), 2B-81-532Z-W (C1-08105), 2B-81-532Z-W (C1-08107), 2B-81-532Z-W (C1-08108), 2B-81-532Z-W (C1-08109), 2B-81-532Z-W (C1-08110), 2B-81-532Z-W (C1-08119), 2B-81-532Z-W (C1-08129), 2B-81-532Z-W (C1-08130), 2B-81-532Z-W (C1-08131), 2B-81-532Z-W (C1-08132), 2B-81-532Z-W (C1-08093), 2B-81-532Z-W (C1-08094), 2B-81-532Z-W (C1-08102), 2B-81-532Z-W (C1-08111), 2B-81-532Z-W (C1-08122), 2B-81-532Z-W (DP-01372), 2B-81-532Z-W (DP-01434), 2B-81-532Z-W (DP-01596), 2B-81-532Z-W (OR-04381), 2B-81-532Z-W (OR-04382), 2B-81-532Z-W (OR-04405), 2B-81-532Z-W (DP-02792), 2B-81-532Z-W (OR-04579), 2B-81-532Z-W (DP-02933), 2B-81-532Z-W (DP-02940), 2B-81-532Z-W (DP-02949), 2B-81-532Z-W (OR-04600), 2B-81-532Z-W (OR-04625), 2B-81-532Z-W (OR-04609), 2B-81-532Z-W (OR-04709), 2B-81-532Z-W (C1-11368), 2B-81-532Z-W (C1-11369), 2B-81-532Z-W (C1-11370), 2B-81-532Z-W (C1-11371), 2B-81-532Z-W (C1-11374), 2B-81-532Z-W (C1-11375), 2B-81-532Z-W (C1-11376), 2B-81-532Z-W (C1-11377), 2B-81-532Z-W (C1-12452), 2B-81-532Z-W (C1 12452), 2B-81-532Z-W (DP-04710), 2B-81-532Z-W (DP-4763), 2B-81-532Z-W (DP-04778), 2B-81-532Z-W (OR-04842), 2B-81-532Z-W (DP-05418), 2B-81-532Z-W (DP 05418), 2B-81-532Z-W (DP-05899), 2B-81-532Z-W (DP-05967), 2B-81-532Z-W (DP-06761), 2B-81-532Z-W (DP-06985), 2B-81-532Z-W (DP-07012), 2B-81-532Z-W (DP-07791), 2B-81-532Z-W (DP-07792); l. TB LEAD, 6F UN-SHROUDED RIGHT HEART CURVE, 020024 - 2B-81-532Z-X (D2-01776), 2B-81-532Z-X (D2-01793), 2B-81-532Z-X (D1-02749), 2B-81-532Z-X (OR-04124), 2B-81-532Z-X (D1-02818), 2B-81-532Z-X (DP-01042), 2B-81-532Z-X (DP-01044), 2B-81-532Z-X (DP-01155), 2B-81-532Z-X (OR-04226), 2B-81-532Z-X (DP 01042), 2B-81-532Z-X (C1-07890), 2B-81-532Z-X (C1-07891), 2B-81-532Z-X (C1-07892), 2B-81-532Z-X (C1-07893), 2B-81-532Z-X (C1-07894), 2B-81-532Z-X (C1-07896), 2B-81-532Z-X (C1-07897), 2B-81-532Z-X (C1-07918), 2B-81-532Z-X (C1-07919), 2B-81-532Z-X (C1-07920), 2B-81-532Z-X (C1-07921), 2B-81-532Z-X (C1-07922), 2B-81-532Z-X (C1-07923), 2B-81-532Z-X (C1-07924), 2B-81-532Z-X (C1-07925), 2B-81-532Z-X (C1-07926), 2B-81-532Z-X (C1-07927), 2B-81-532Z-X (C1-07928), 2B-81-532Z-X (C1-07929), 2B-81-532Z-X (C1-07930), 2B-81-532Z-X (C1-07931), 2B-81-532Z-X (C1-07932), 2B-81-532Z-X (C1-07933), 2B-81-532Z-X (C1-07934), 2B-81-532Z-X (C1-07935), 2B-81-532Z-X (C1-07936), 2B-81-532Z-X (C1-07937), 2B-81-532Z-X (C1-07938), 2B-81-532Z-X (C1-07898), 2B-81-532Z-X (C2-07889), 2B-81-532Z-X (C1-07895), 2B-81-532Z-X (OR-04274), 2B-81-532Z-X (C1-07943), 2B-81-532Z-X (C1-07944), 2B-81-532Z-X (DP-01438), 2B-81-532Z-X (DP-01375), 2B-81-532Z-X (OR-04325), 2B-81-532Z-X (DP-01573), 2B-81-532Z-X (DP-01597), 2B-81-532Z-X (DP-01584), 2B-81-532Z-X (DP-01677), 2B-81-532Z-X (DP-01683), 2B-81-532Z-X (OR-04376), 2B-81-532Z-X (OR-04378), 2B-81-532Z-X (OR-04375), 2B-81-532Z-X (OR-04379), 2B-81-532Z-X (OR-04374), 2B-81-532Z-X (C1-08600), 2B-81-532Z-X (C1-08654), 2B-81-532Z-X (C1-08599), 2B-81-532Z-X (C1-08653), 2B-81-532Z-X (OR-04377), 2B-81-532Z-X (C1-08630), 2B-81-532Z-X (C1-08626), 2B-81-532Z-X (C1-08617), 2B-81-532Z-X (C1-08618), 2B-81-532Z-X (C1-08629), 2B-81-532Z-X (C1-08622), 2B-81-532Z-X (C1-08631), 2B-81-532Z-X (OR-04401), 2B-81-532Z-X (C1-08624), 2B-81-532Z-X (C1-08623), 2B-81-532Z-X (C1-08628), 2B-81-532Z-X (C1-08625), 2B-81-532Z-X (C1-08602), 2B-81-532Z-X (C1-08615), 2B-81-532Z-X (C1-08614), 2B-81-532Z-X (C1-08613), 2B-81-532Z-X (C1-08616), 2B-81-532Z-X (C1-08627), 2B-81-532Z-X (DP-03426), 2B-81-532Z-X (DP-03441), 2B-81-532Z-X (DP-03541), 2B-81-532Z-X (DP-03720), 2B-81-532Z-X (DP-04691), 2B-81-532Z-X (DP 04691), 2B-81-532Z-X (DP-04711), 2B-81-532Z-X (DP-04712), 2B-81-532Z-X (DP-04814), 2B-81-532Z-X (DP-04820), 2B-81-532Z-X (DP-05266), 2B-81-532Z-X (DP-05452), 2B-81-532Z-X (DP-05509), 2B-81-532Z-X (DP-05790), 2B-81-532Z-X (DP-05792), 2B-81-532Z-X (DP-05878), 2B-81-532Z-X (DP-05837), 2B-81-532Z-X (DP-05890), 2B-81-532Z-X (DP-05915), 2B-81-532Z-X (DP-05517), 2B-81-532Z-X (DP-05891), 2B-81-532Z-X (DP-07985); m. TB LEAD 4F UNSHROUDED CONVENIENCE KIT, TBK04110USG - 3H-81-003Z-A (DP-03329); n. TB LEAD 5F UNSHROUDED CONVENIENCE KIT, TBK05110USG - 3H-81-005Z-A (DP-01161), 3H-81-005Z-A (DP-02004), 3H-81-005Z-A (DP-02009), 3H-81-005Z-A (DP-02435), 3H-81-005Z-A (DP-02884), 3H-81-005Z-A (DP02884), 3H-81-005Z-A (DP 02884), 3H-81-005Z-A (DP-07032); o. TB 6F U CONVENIENCE KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBK06110USG - 3H-81-007Z-A (D1-02232), 3H-81-007Z-A (D1-02520), 3H-81-007Z-A (D1-02833), 3H-81-007Z-A (DP-01376), 3H-81-007Z-A (DP-02083), 3H-81-007Z-A (DP-02408), 3H-81-007Z-A (DP-02885), 3H-81-007Z-A (DP-03724), 3H-81-007Z-A (DP-04453), 3H-81-007Z-A (DP-05047), 3H-81-007Z-A (DP-06146), 3H-81-007Z-A (DP-06147), 3H-81-007Z-A (OR-04888), 3H-81-007Z-A (DP-07005), 3H-81-007Z-A (DOR05934); p. TBRH 4F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBRHK04110USG - 3H-81-043Z-A (DP-03330), 3H-81-043Z-A (DP-04258); q. TBRH 5F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 5F S10CM D15CM, TBRHK05110USG - 3H-81-041Z-A (DP-03051); r. TBRH 6F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBRHK06110USG - 3H-81-034Z-A (FP-054291), 3H-81-034Z-A (FP-54291), 3H-81-034Z-A (C1-08813), 3H-81-034Z-A (DP-02166); s. TBV 4F 60 DEGREE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBVK04110USG - 3H-81-045Z-A (DP-03397); t. TBJ 4F ATRIAL J CURVE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBJK04110USG - 3H-81-047Z-A (DP-03396); u. TBV 6F 60 DEGREE U CONV. KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBVK06110USG - 3H-81-035Z-A (FP-55411)
Where was it sold?
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, HI, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PR, RI, TN, TX, UT, VA, WA. Countries of AUSTRIA, BENIN REPUBLIC, BOLIVIA, BRAZIL, BULGARIA, CANADA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GEORGIA, GERMANY, GREECE, GUATEMALA, INDIA, IRAN, IRAN, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, MACEDONIA, MAURITIUS, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SENEGAL, SOUTH AFRICA, TAIWAN, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Oscor
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS I | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS I | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel recalled | Oscor | Packaging Defects | MA |
| Device | CLASS II | Destino Twist 14F (also branded as Guidestar 14F) recalled by Oscor | Oscor | Other | PA, TN |
| Device | CLASS II | AngioDynamics SafeSheath Ultralite 10F recalled by Oscor | Oscor | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |