Medical DeviceNov 15, 2017
Epimed International RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units recall — FDA Z-0087-2018
Potential for partially incomplete seal of product, impacting sterility.
Class IIFDA: TerminatedEpimed International
27,577medical device recall records
2,338FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 905
27,577 detailed records are currently available in this category.
Medical DeviceNov 15, 2017
Encore Medical Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET recall — FDA Z-0065-2018
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Class IIFDA: OngoingEncore Medical, Lp
Medical DeviceNov 15, 2017
Epimed International TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated recall — FDA Z-0089-2018
Potential for partially incomplete seal of product, impacting sterility.
Class IIFDA: TerminatedEpimed International
Medical DeviceNov 15, 2017
Teleflex Medical WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier recall — FDA Z-0083-2018
The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.
Class IIFDA: TerminatedTeleflex Medical
Medical DeviceNov 15, 2017
Terumo BCT HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO recall — FDA Z-0075-2018
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
Class IIFDA: TerminatedTerumo BCT, Inc.
Medical DeviceNov 15, 2017
Becton Dickinson & Company BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium recall — FDA Z-0084-2018
After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case…
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceNov 15, 2017
Encore Medical Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1 recall — FDA Z-0066-2018
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Class IIFDA: OngoingEncore Medical, Lp
Medical DeviceNov 15, 2017
Encore Medical Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET recall — FDA Z-0064-2018
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Class IIFDA: OngoingEncore Medical, Lp
Medical DeviceNov 15, 2017
Limacorporate S.p.A Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during recall — FDA Z-0068-2018
An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the…
Class IIFDA: CompletedLimacorporate S.p.A
Medical DeviceNov 15, 2017
Aaren Scientific AERO IOL Injection System containing 10 Z28 Cartridges per box, Part recall — FDA Z-0071-2018
The recommended storage temperature on the label is incorrect.
Class IIFDA: TerminatedAaren Scientific Inc.
Medical DeviceNov 15, 2017
Boston Scientific VIGILANT X4 CRT-D, Model G247, Sterile recall — FDA Z-0079-2018
The devices have an incorrect firmware configuration.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceNov 15, 2017
Bioseal Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) recall — FDA Z-0085-2018
Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
Class IIFDA: CompletedBioseal Corporation
Medical DeviceNov 15, 2017
BioMerieux SA NucliSENS Lysis Buffer Extended lot for RES 76675 recall — FDA Z-0086-2018
Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially…
Class IIFDA: TerminatedBioMerieux SA
Medical DeviceNov 15, 2017
Windstone Medical Packaging AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO recall — FDA Z-0069-2018
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Class IIFDA: TerminatedWindstone Medical Packaging, Inc.
Medical DeviceNov 15, 2017
Zimmer Biomet Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee recall — FDA Z-0070-2018
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 15, 2017
Invivo Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system recall — FDA Z-0082-2018
Intermittent communication between the host system and the Flex Cardio
Class IIFDA: TerminatedInvivo Corporation
Medical DeviceNov 15, 2017
Epimed International COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each recall — FDA Z-0088-2018
Potential for partially incomplete seal of product, impacting sterility.
Class IIFDA: TerminatedEpimed International
Medical DeviceNov 15, 2017
Biomerieux VITEK2 GP-ID, REF 21342 IVD recall — FDA Z-0074-2018
Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with…
Class IIFDA: TerminatedBiomerieux Inc.
Medical DeviceNov 15, 2017
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system recall — FDA Z-0063-2018
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
Class IIFDA: OngoingNorth Star Imaging Inc.
Medical DeviceNov 15, 2017
Sorin Group USA FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous recall — FDA Z-0076-2018
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceNov 15, 2017
Northgate Technologies Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS recall — FDA Z-0073-2018
The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled…
Class IIFDA: TerminatedNorthgate Technologies, Inc.
Medical DeviceNov 8, 2017
Biosense Webster THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT recall — FDA Z-0058-2018
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters.…
Class IIFDA: TerminatedBiosense Webster, Inc.
Medical DeviceNov 8, 2017
Smiths Medical ASD CADD(TM) Medication Cassette Reservoir with clamp and female Luer. recall — FDA Z-0061-2018
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceNov 8, 2017
Biosense Webster THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S recall — FDA Z-0054-2018
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters.…
Class IIFDA: TerminatedBiosense Webster, 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.