Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 59 of 63
Medtronic MiniMed
Class II Terminated
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm s...
Reason: Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have ...
Z-1986-2013 August 28, 2013 Northridge, CA
Getinge USA Inc
Class II Terminated
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 1462...
Reason: AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal ste...
Z-1994-2013 August 28, 2013 Rochester, NY
SpineFrontier, Inc.
Class II Terminated
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift L...
Reason: Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated w...
Z-1958-2013 August 21, 2013 Beverly, MA
Steritec Products Mfc. Co., Inc.
Class II Terminated
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Bi...
Reason: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout t...
Z-1823-2013 August 7, 2013 Englewood, CO
Steritec Products Mfc. Co., Inc.
Class II Terminated
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integr...
Reason: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout t...
Z-1828-2013 August 7, 2013 Englewood, CO
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Class II Terminated
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Reason: Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Z-1867-2013 August 7, 2013 Bozeman, MT
Steritec Products Mfc. Co., Inc.
Class II Terminated
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended ...
Reason: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout t...
Z-1824-2013 August 7, 2013 Englewood, CO
Steritec Products Mfc. Co., Inc.
Class II Terminated
Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout In...
Reason: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout t...
Z-1829-2013 August 7, 2013 Englewood, CO
Steritec Products Mfc. Co., Inc.
Class II Terminated
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained B...
Reason: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout t...
Z-1822-2013 August 7, 2013 Englewood, CO
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Class II Terminated
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Reason: Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Z-1868-2013 August 7, 2013 Bozeman, MT
KooJoo Trading Company
Class II Terminated
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distri...
Reason: Lancets were not sterilized within the dose range established by sterilization validation.
Z-1729-2013 July 24, 2013 Gimpo City, Gyeongki-Do, N/A
DeRoyal Industries Inc
Class II Terminated
GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Reason: DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.
Z-1692-2013 July 17, 2013 Powell, TN
Clorox Healthcare Holdings, LLC (dba HealthLink)
Class II Terminated
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
Reason: Due to lack of sterilization.
Z-1656-2013 July 10, 2013 Jacksonville, FL
Clorox Healthcare Holdings, LLC (dba HealthLink)
Class II Terminated
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
Reason: Due to lack of sterilization.
Z-1654-2013 July 10, 2013 Jacksonville, FL
Clorox Healthcare Holdings, LLC (dba HealthLink)
Class II Terminated
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
Reason: Due to lack of sterilization.
Z-1655-2013 July 10, 2013 Jacksonville, FL
Bard Peripheral Vascular Inc
Class II Terminated
USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745...
Reason: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were...
Z-1529-2013 June 19, 2013 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogen...
Reason: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were...
Z-1526-2013 June 19, 2013 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, I...
Reason: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were...
Z-1528-2013 June 19, 2013 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use,...
Reason: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were...
Z-1527-2013 June 19, 2013 Tempe, AZ
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room...
Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue ste...
Z-1489-2013 June 12, 2013 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and oper...
Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue ste...
Z-1497-2013 June 12, 2013 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operati...
Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue ste...
Z-1499-2013 June 12, 2013 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating...
Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue ste...
Z-1503-2013 June 12, 2013 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operat...
Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue ste...
Z-1504-2013 June 12, 2013 Portage, MI
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room p...
Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue ste...
Z-1496-2013 June 12, 2013 Portage, MI