Medical DeviceNov 9, 2016
Unomedical As Comfort 5+5 Pack w/110cm Tube & 17mm Cann recall — FDA Z-0358-2017
Tubing detachment
Class IIFDA: TerminatedUnomedical As
28,535medical device recall records
2,363FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1019
28,535 detailed records are currently available in this category.
Medical DeviceNov 9, 2016
Unomedical As AC TenderLink 13/30 10 pcs recall — FDA Z-0357-2017
Tubing detachment
Class IIFDA: TerminatedUnomedical As
Medical DeviceNov 9, 2016
Unomedical As Contact Detach, 8mm, 23", G29 recall — FDA Z-0356-2017
Tubing detachment
Class IIFDA: TerminatedUnomedical As
Medical DeviceNov 9, 2016
Spacelabs Healthcare Xhibit Central Station, Model 96102 recall — FDA Z-0332-2017
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
Class IIFDA: TerminatedSpacelabs Healthcare Inc.
Medical DeviceNov 9, 2016
Azer Scientific Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles recall — FDA Z-0330-2017
Out of Specification Microbiological test results
Class IIFDA: TerminatedAzer Scientific, Inc.
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm recall — FDA Z-0342-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Unomedical As SureT G29 6mm, 18", Paradigm recall — FDA Z-0360-2017
Tubing detachment
Class IIFDA: TerminatedUnomedical As
Medical DeviceNov 9, 2016
Arrow International HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow recall — FDA Z-0331-2017
Labeling inconsistency
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceNov 9, 2016
Medline Industries Rigid Suction Canister 3000 CC and 2000 CC recall — FDA Z-0352-2017
Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceNov 9, 2016
Epimed International 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for recall — FDA Z-0086-2017
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain…
Class IIFDA: TerminatedEpimed International, Inc.
Medical DeviceNov 9, 2016
Unomedical As Silhouette Paradigm 13mm, 18" recall — FDA Z-0359-2017
Tubing detachment
Class IIFDA: TerminatedUnomedical As
Medical DeviceNov 9, 2016
Stryker Sustainability Solutions Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs recall — FDA Z-0324-2017
Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or…
Class IIFDA: TerminatedStryker Sustainability Solutions
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/MP XF/7FR/90CM recall — FDA Z-0335-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER 40XF 5F 90CM recall — FDA Z-0347-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Hospira Symbiq Two Channel Infuser recall — FDA Z-0354-2017
Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply…
Class IIFDA: TerminatedHospira Inc.
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM recall — FDA Z-0345-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Encore Medical Empowr PS Knee System Box Cut Guide recall — FDA Z-0325-2017
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the…
Class IIFDA: TerminatedEncore Medical, Lp
Medical DeviceNov 9, 2016
Hill-Rom Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed recall — FDA Z-0326-2017
Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling…
Class IIFDA: TerminatedHill-Rom, Inc.
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER MPXF 5F 90CM recall — FDA Z-0344-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/40XF/8FR/90CM recall — FDA Z-0341-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
B. Braun Medical Affected Pain Control Tray Component recall — FDA Z-0327-2017
B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection,…
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceNov 9, 2016
Hospira Symbiq One Channel Infuser recall — FDA Z-0353-2017
Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply…
Class IIFDA: TerminatedHospira Inc.
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/40DEG XF/6FR/90CM recall — FDA Z-0338-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Unomedical As Infusion Set, Comfort, 23" Hosp 10 recall — FDA Z-0355-2017
Tubing detachment
Class IIFDA: TerminatedUnomedical As
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.