Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IITM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IIZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 00234701714 00234701716 00234701718 00234701802 00234701804 00234701806 00234701808 00234701810 00234701812 00234701814 00234701816 00234701818 47235701704 47235701706 47235701708 47235701710 47235701712 47
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IINCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012 0202265014
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IINCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IIVarious Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IICoorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 32855510843 32855510844
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IISidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IITrabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913 00434811013 00434811017 00434811113 00434811213 00434811217 00434811313 00434811413 00434811417 00434811513 00434811613 00434811713 00434811813 004349
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceZimmer Biomet, Inc.Class IIBF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- 2019-11-13FDA-DeviceHelena Laboratories, Corp.Class IIISPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass IIArgon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass IIArgon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass IIArgon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass II(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass IIArgon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass IIArgon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass II(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Caro
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass IIArgon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceArgon Medical Devices, IncClass II(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- 2019-11-13FDA-DeviceBiomedical Polymers, Inc.Class IIIManual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
- 2019-11-13FDA-DeviceBiomedical Polymers, Inc.Class IIIHemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.
The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
- 2019-11-13FDA-DeviceBecton Dickinson & CompanyClass II13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.
A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
- 2019-11-13FDA-DeviceBecton Dickinson & CompanyClass IIMaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ8003 MZ9266 MZ9267 MZ9272 MZ9273 MZ9274 MZ9275 MZ9276 MZ9277 MZ9278 MZ9279 MZ9280 MZ9281 MZ9283 MZ9287 MZ9288 MZ9289 MZ9290 MZ9292 MZ9293 MZ9294 MZ9300 MZ9301 MZ9302 MZ9313 MZ9323 MZ9324 MZ9325 MZ9326 MZ9327 MZ9329 MZT1003 MZT1004 MZX5
BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection.
- 2019-11-13FDA-DeviceRandox Laboratories Ltd.Class IILiquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimensi
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.
- 2019-11-13FDA-DeviceRandox Laboratories Ltd.Class IIRheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syp
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.
- 2019-11-13FDA-DeviceGE Healthcare, LLCClass IIGiraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
- 2019-11-13FDA-DeviceBaxter Healthcare CorporationClass IIPrismaflex Control Unit, software versions below 7.21
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- 2019-11-13FDA-DeviceBaxter Healthcare CorporationClass IIPrismaflex Control Unit, software versions below 7.21
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- 2019-11-13FDA-DeviceBaxter Healthcare CorporationClass IIPrismaflex Control Unit, software versions below 7.21
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- 2019-11-13FDA-DeviceBaxter Healthcare CorporationClass IIPrismaflex Control Unit, software versions below 7.21
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
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