Medical DeviceSep 17, 2014
Wright Medical Technology CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF recall — FDA Z-2607-2014
Plates manufactured from an incorrect raw material.
Class IIFDA: TerminatedWright Medical Technology, Inc.
30,447medical device recall records
2,766FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1263
30,447 detailed records are currently available in this category.
Medical DeviceSep 17, 2014
Stryker Spine Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part recall — FDA Z-2627-2014
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Class IIFDA: TerminatedStryker Spine
Medical DeviceSep 17, 2014
Baxter Healthcare ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip recall — FDA Z-2614-2014
Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the…
Class IIFDA: TerminatedBaxter Healthcare Corp
Medical DeviceSep 17, 2014
Primus Medical Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress recall — FDA Z-2596-2014
The firm found that the top cover of the mattresses were delaminating.
Class IIFDA: TerminatedPrimus Medical LLC
Medical DeviceSep 17, 2014
Concentric Medical Merci Retriever Intended to restore blood flow in the neurovasculature by recall — FDA Z-2598-2014
Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
Class IIFDA: TerminatedConcentric Medical Inc.
Medical DeviceSep 10, 2014
Customed Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY recall — FDA Z-2476-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION recall — FDA Z-2533-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
OrthoPediatrics ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm recall — FDA Z-2560-2014
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Class IIFDA: TerminatedOrthoPediatrics Corp
Medical DeviceSep 10, 2014
Customed LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" recall — FDA Z-2327-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN recall — FDA Z-2462-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER recall — FDA Z-2388-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE recall — FDA Z-2381-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE recall — FDA Z-2373-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed ACDFPACK SURGICAL CENTER, CODE 900-2917 recall — FDA Z-2511-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) recall — FDA Z-2392-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used recall — FDA Z-2588-2014
The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Class IIFDA: TerminatedGalt Medical Corporation
Medical DeviceSep 10, 2014
Zimmer Natural-Knee System Patella Bushings recall — FDA Z-2583-2014
Zimmer received a trend of complaints indicating corrosion of product.
Class IIFDA: TerminatedZimmer, Inc.
Medical DeviceSep 10, 2014
Customed Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) recall — FDA Z-2481-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) recall — FDA Z-2489-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" recall — FDA Z-2431-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLICATOR recall — FDA Z-2403-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 recall — FDA Z-2320-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent recall — FDA Z-2303-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
Medical DeviceSep 10, 2014
Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc recall — FDA Z-2308-2014
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient…
Class IFDA: TerminatedCustomed, Inc.
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.