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Ra Medical Systems, Inc.

Ra Medical Systems, Inc. Recalls

All product recalls associated with Ra Medical Systems, Inc..

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1641–1660 of 3680 recalls

DABRA Laser (Ra Medical Systems) - Software Performance Risk (2020)

A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.

FDAJan 23, 2020AL, AZ, CA +19 more• Ra Medical Systems, Inc.

PTS Detect Cotinine (Polymer Technology) - Clearance Lack (2020)

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

FDAJan 21, 2020Nationwide• Polymer Technology Systems, Inc.

Columbus Tibia Offset (Aesculap) - Polyethylene Particle Risk (2020)

Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

FDA

1...81 828384 85...184

Page 83 of 184Next

Jan 21, 2020

Nationwide

• Aesculap Implant Systems LLC

Columbus CR/PS Tibial Plateau (Aesculap) - Polyethylene Particle Risk (2020)

Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

FDAJan 21, 2020Nationwide• Aesculap Implant Systems LLC

Columbus CRA/PSA Tibial Plateau (Aesculap) - Polyethylene Particle Risk (2020)

Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

FDAJan 21, 2020Nationwide• Aesculap Implant Systems LLC

Columbus R/PS Tibial Plateau (Aesculap) - Polyethylene Particle Risk (2020)

Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

FDAJan 21, 2020Nationwide• Aesculap Implant Systems LLC

Columbus CR/PS Tibial Plateau Plasmapore (Aesculap) - Polyethylene Particle Risk (2020)

Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

FDAJan 21, 2020Nationwide• Aesculap Implant Systems LLC

Advanced Perfusion System Roller Pump (Terumo) – shaft failure risk (2020)

These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.

FDAJan 10, 2020Nationwide• Terumo Cardiovascular Systems Corporation

Perfusion Assembly Pump Guts (Terumo) – shaft failure risk (2020)

FDAJan 10, 2020Nationwide• Terumo Cardiovascular Systems Corporation

Inpatient Dialysis Kit (Custom Healthcare) – latex component issue (2019)

A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.

FDADec 20, 2019IL• Custom Healthcare Systems, Inc.

CombiDiagnost GCF (Philips) – table control error (2019)

When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.

FDADec 19, 2019Nationwide• Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany

CombiDiagnost PCF (Philips) – table control error (2019)

FDADec 19, 2019Nationwide• Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany

CardioChek Plus Analyzer (PTS) – Battery Terminal Problem (2019)

One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

FDADec 2, 2019Nationwide• Polymer Technology Systems, Inc.

CardioChek Plus Analyzer (PTS) – Battery Terminal Problem (2019)

FDADec 2, 2019Nationwide• Polymer Technology Systems, Inc.

CardioChek Starter Kit (PTS) – Battery Terminal Problem (2019)

FDADec 2, 2019Nationwide• Polymer Technology Systems, Inc.

BOND Polymer Refine Detection Kit, Catalog No. DS9800. T... (Leica Microsystems, Inc.) – bond polymer refine detection kits (d... (2019)

BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.

FDANov 18, 2019Nationwide• Leica Microsystems, Inc.

Queen Victoria Broccoli (Stern Produce) – bacterial contamination (2019)

Firm is recalling one lot of baby broccoli because it may be contaminated with bacteria contained in dripping ice water from a drain tray in the cooler.

Class IIModerate

FDANov 18, 2019AZ, IN• Stern Produce Company Inc.

Medtronic Affinity, 38um Arterial Filter, Catalog number ... (Medtronic Perfusion Systems) – plastic contamination (2019)

Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.

FDANov 14, 2019CA• Medtronic Perfusion Systems

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM (Aesculap Implant Systems LLC) – nonfunctional key due to the potentia... (2019)

Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

FDANov 12, 2019Nationwide• Aesculap Implant Systems LLC

Stryker Omnifit Crossfire Insert (Howmedica) – Missing Locking Wire (2019)

May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

FDANov 7, 2019CA, FL, GA +6 more• Howmedica Osteonics Corp.