Medical DeviceFeb 16, 2022
Microbiologics KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM) recall — FDA Z-0582-2022
Potential contamination with S. epidermidis E. coli and S. warneri.
Class IIFDA: TerminatedMicrobiologics Inc.
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 451
24,239 detailed records are currently available in this category.
Medical DeviceFeb 16, 2022
E25Bio COVID-19 Direct Antigen Rapid Test recall — FDA Z-0564-2022
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
Class IFDA: TerminatedE25Bio, Inc.
Medical DeviceFeb 16, 2022
Mallinckrodt Pharmaceuticals Ireland THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA recall — FDA Z-0567-2022
This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process…
Class IIFDA: OngoingMallinckrodt Pharmaceuticals Ireland Ltd
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR recall — FDA Z-0609-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE recall — FDA Z-0615-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed recall — FDA Z-0613-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
Microbiologics KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) recall — FDA Z-0581-2022
The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot…
Class IIIFDA: TerminatedMicrobiologics Inc.
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System recall — FDA Z-0619-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR recall — FDA Z-0605-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR recall — FDA Z-0606-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System recall — FDA Z-0611-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T recall — FDA Z-0601-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T recall — FDA Z-0602-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
Smith & Nephew Acufex Access Advanced Positioning Kit - indicated for use to position and recall — FDA Z-0635-2022
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceFeb 16, 2022
Microbiologics QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) recall — FDA Z-0589-2022
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the…
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System recall — FDA Z-0590-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
Microbiologics LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic recall — FDA Z-0586-2022
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the…
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA recall — FDA Z-0597-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx recall — FDA Z-0617-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone recall — FDA Z-0621-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
Microbiologics QC Sets and Panels: KWIK-STIK" 2 Pack recall — FDA Z-0584-2022
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System recall — FDA Z-0618-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System recall — FDA Z-0598-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 16, 2022
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484 recall — FDA Z-0578-2022
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
Class IIFDA: OngoingBaxter Healthcare Corporation
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.