Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 15 of 63
Orthosoft, Inc. dba Zimmer CAS
Class II Ongoing
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Reason: The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is...
Z-0721-2022 March 9, 2022 Montreal
Smith & Nephew, Inc.
Class II Ongoing
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Reason: Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Z-0635-2022 February 16, 2022 Memphis, TN
Mallinckrodt Pharmaceuticals Ireland Ltd
Class II Ongoing
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Reason: 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 sterilizatio...
Z-0567-2022 February 16, 2022 Dublin 15, N/A
Young Dental Mfg Co I LLC
Class II Ongoing
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilizat...
Reason: The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
Z-0555-2022 February 9, 2022 Earth City, MO
Howmedica Osteonics Corp.
Class II Ongoing
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalizati...
Reason: Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N:...
Z-0459-2022 January 12, 2022 Mahwah, NJ
Karl Storz Endoscopy
Class II Ongoing
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X...
Reason: To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters gr...
Z-0442-2022 January 5, 2022 El Segundo, CA
Medicalplastic S.R.L.
Class II Ongoing
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Reason: Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Te...
Z-0245-2022 November 24, 2021 Milan, N/A
ADRIA SRL
Class II Terminated
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Reason: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Z-0146-2022 October 27, 2021 San Giovanni In Persiceto, N/A
ADRIA SRL
Class II Terminated
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
Reason: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Z-0145-2022 October 27, 2021 San Giovanni In Persiceto, N/A
ADRIA SRL
Class II Terminated
Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
Reason: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Z-0144-2022 October 27, 2021 San Giovanni In Persiceto, N/A
Smiths Medical ASD Inc.
Class II Terminated
smiths medical portex Loss of Resistance Device, REF 100/398/000
Reason: The labeling was missing information on sterilization and prohibition of reuse.
Z-0152-2022 October 27, 2021 Minneapolis, MN
Cypress Medical Products LLC
Class II Terminated
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Reason: Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators di...
Z-2473-2021 September 22, 2021 Richmond, VA
Aspen Surgical Products, Inc.
Class II Terminated
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Reason: Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the ...
Z-2388-2021 September 8, 2021 Caledonia, MI
Aspen Surgical Products, Inc.
Class II Terminated
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Reason: Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the ...
Z-2390-2021 September 8, 2021 Caledonia, MI
Aspen Surgical Products, Inc.
Class II Terminated
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Reason: Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the ...
Z-2389-2021 September 8, 2021 Caledonia, MI
Delta Med SpA
Class II Ongoing
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2296-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2295-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2301-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2298-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2304-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2299-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i)...
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2297-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2303-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2302-2021 August 25, 2021 Viadana, N/A
Delta Med SpA
Class II Ongoing
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Z-2300-2021 August 25, 2021 Viadana, N/A