Medical DeviceMar 6, 2019
Madison Polymeric Engineering Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z recall — FDA Z-0969-2019
The product is contaminated with Pseudomonas.
Class IIFDA: TerminatedMadison Polymeric Engineering
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 175
Records are ordered by the best available source date.
Medical DeviceMar 6, 2019
Cook Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order recall — FDA Z-0968-2019
There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Class IIFDA: TerminatedCook Inc.
Medical DeviceMar 6, 2019
Arrow International AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB recall — FDA Z-0950-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Zimmer Biomet Spine Vitality Spinal Fixation System recall — FDA Z-0866-2019
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated…
Class IIFDA: TerminatedZimmer Biomet Spine Inc.
Medical DeviceMar 6, 2019
Arrow International 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow recall — FDA Z-0944-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Arrow International AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP recall — FDA Z-0951-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Elekta Monaco Radiation Treatment Planning (RTP) System recall — FDA Z-0965-2019
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan…
Class IIFDA: TerminatedElekta, Inc.
Medical DeviceMar 6, 2019
Abbott Vascular PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use recall — FDA Z-0960-2019
Incorrect expiration being entered for one lot.
Class IIFDA: TerminatedAbbott Vascular
Medical DeviceMar 6, 2019
Zimmer Biomet Spine Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance recall — FDA Z-0868-2019
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated…
Class IIFDA: TerminatedZimmer Biomet Spine Inc.
Medical DeviceMar 6, 2019
Arrow International AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB recall — FDA Z-0952-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Arrow International AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow recall — FDA Z-0948-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Arrow International AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow recall — FDA Z-0943-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Zimmer Biomet Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 recall — FDA Z-0937-2019
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 6, 2019
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification recall — FDA Z-0961-2019
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
Class IIFDA: TerminatedAlcon Research Laboratories Ltd.
Medical DeviceMar 6, 2019
Arrow International AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow recall — FDA Z-0956-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Arrow International AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow recall — FDA Z-0954-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Arrow International AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow recall — FDA Z-0955-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
American Contract Systems Bag size #4 Custom Convenience Kits Usage: Surgical convenience recall — FDA Z-0964-2019
Potential that product has not reached complete sterilization,
Class IIFDA: TerminatedAmerican Contract Systems, Inc.
Medical DeviceMar 6, 2019
Arrow International AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow recall — FDA Z-0946-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Shimadzu Medical Systems Usa Com BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM recall — FDA Z-0959-2019
Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the…
Class IIFDA: TerminatedShimadzu Medical Systems Usa Com
Medical DeviceMar 6, 2019
Cardinal Health 200 Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" recall — FDA Z-0957-2019
Curity All Purpose Sponges were not sterilized and distributed
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceMar 6, 2019
BrosMed Medical Co Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter recall — FDA Z-0963-2019
Incorrect (higher) Rated Burst Pressure information printed on label.
Class IIFDA: TerminatedBrosMed Medical Co., Ltd.
Medical DeviceMar 6, 2019
Arrow International AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow recall — FDA Z-0945-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Exactech Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are recall — FDA Z-0958-2019
Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem…
Class IIFDA: TerminatedExactech, Inc.
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.